Ryan P. Daly, MD

Cardiology Business

The State of the TAVR Market in 2025

2025 has been a year of many cardiology trends, with one stand out technology capturing much of the spotlight – transcatheter aortic valves. To keep our valves in a row, Cardiac Wire has compiled a breakdown of the top TAVR makers, movers, shakers, and potential future players. 

Starting off with the biggest player, Edwards Lifesciences controls about 60-70% of the U.S. TAVR market and has some of the most proven tech in the segment…

• Edwards markets the balloon-expandable SAPIEN platform, which is the longest‑established TAVR system (FDA-approved since 2011).
• Earlier this year, the FDA approved SAPIEN’s use for lower-risk and asymptomatic patients thanks to positive results from the EARLY TAVR trial.
• Shoring up its TAVR pipeline for AR therapy, Edwards also acquired JenaValve and JC Medical in 2024 (although the FTC is now trying to block JenaValve).

Medtronic isn’t far behind and essentially makes up the remainder of the market, with 30-35% of TAVR procedures worldwide using a Medtronic valve.

• The company’s product line includes the CoreValve / Evolut series (self‑expanding nitinol valves).
• Some studies, like SMART, suggest Medtronic’s valves could lead to better outcomes in patients with smaller aortic annuli.

Abbott doesn’t intend to let TAVR stay a two horse race for long, and is working on gaining regulatory approval for its own devices.

• Abbott currently produces the Navitor TAVR system (successor to its older Portico), which is in active clinical trials including the ENVISION pivotal study.

Boston Scientific was a TAVR player up until earlier this year when it quietly discontinued its Acurate product line due to unfavorable trial results and potential stroke risks.

So who is left to challenge Edwards and Medtronic for the TAVR throne? 

• Anteris Technologies – Anteris’ balloon-expandable DurAVR THV system looks and works like a human valve (all other TAVRs have three fixed leaflets), and claims calcification benefits.
• JenaValve Technology – Originally Chinese but facing acquisition from Edwards, the JenaValve Trilogy system is undergoing FDA trials for aortic regurgitation and might allow more complex aortic access methods.
• JC Medical – Now also owned by Edwards outside of China, the J‑Valve system is used for both AS/regurgitation and has multiple trials underway.
• Meril Life Sciences – Developer of the Myval TAVR system, India’s first homegrown THV, which launched commercially in India and was CE‑marked in 2019.

The Takeaway

TAVR is certainly here to stay, and while it’s been dominated by two companies for most of its short history, the competition could just be getting started.

Personalized Plaque Analysis Now With Medicare Coverage

Heartflow’s Plaque Analysis is now reimbursable thanks to Medicare’s new coverage for AI-enabled plaque analysis of eligible patients with coronary artery disease.

Tempus Receives FDA 510(k) Clearance for Tempus ECG-Low EF

Tempus announces the expansion of its Tempus ECG-AI portfolio with Tempus ECG-Low EF, software intended for use to analyze 12-lead ECG recordings and detect signs associated with having a low left ventricular ejection fraction (LVEF less than or equal to 40%) in patients 40 years of age or older at risk of heart failure. It is not intended as a stand-alone diagnostic and positive results may suggest the need for further clinical evaluation. For Full Indications for Use, visit here.

Automated and Intelligent EP Reporting

EP ablation procedures are difficult, but your EP reporting process shouldn’t be. See how GE HealthCare’s Centricity EP Structured Reporting allows for quick, accurate, and complete reporting in as few steps as possible.

The Wire

• Edwards’ TAVR-AR Problem: The FTC just voted 3-0 to block Edwards Lifesciences’ $945M acquisition of JenaValve, arguing that it would wipe out competition if Edwards owned the two most advanced TAVR devices for aortic regurgitation. Edwards made a power move into the TAVR-AR space last summer, acquiring the only two TAVR developers with ongoing U.S.-based AR trials (JenaValve and JC Medical). However, the FTC says the deals would stifle innovation, limit patient access, and raise prices, claims that Edwards and JenaValve plan to fight in court.

• Semaglutide’s Cost-Benefit Disconnect: A JAMA study of 23,500+ adults showed that semaglutide (Ozempic/Wegovy) drives weight and cardiometabolic improvements, but might still lead to higher healthcare spending (even if you exclude the GLP-1’s costs). The study’s semaglutide population shed ~4% of their weight over their 13th to 24th months of treatment, while lowering their blood pressure, cholesterol, and A1c. However, the semaglutide users still had ~$80 higher monthly healthcare costs, calling into question previous claims that GLP-1s “will pay for themselves” by reducing downstream healthcare costs.

• DCB NTAP: Boston Scientific scored a big Medicare win for its AGENT drug-coated balloon, used to treat coronary in-stent restenosis. CMS granted the AGENT DCB a New Technology Add-on Payment, giving hospitals extra reimbursement for eligible inpatient cases starting in October, and joining an outpatient Transitional Pass-Through payment that was effective January 1, 2025.  The AGENT DCB gained FDA approval last year, after over 100k treatments internationally, and the new reimbursements should help drive U.S. adoption.

• Pregabalin’s HF Risks: A new Medicare study suggests older adults taking pregabalin for chronic pain treatment could face higher HF risks than those taking gabapentin. The 246k patient study found that pregabalin users had more HF hospitalizations and emergency visits (18.2 vs 12.5 per 1,000 person-years) and that HF risk was particularly elevated in those with CVD history. Researchers now urge careful CV assessment before prescribing pregabalin to older patients, noting that even small absolute risk increases create healthcare burdens.

• Heartflow Shares Jump 50% in IPO: Shares of cardiac AI company Heartflow jumped 50% on August 8, the first day of trading following the company’s IPO. Heartflow raised $317M by issuing 16.7M shares at $19 each, up sharply from the $215M estimated the week before the IPO. That would provide a significant cash infusion for a company that’s already raised a stunning amount of capital (estimated $927M before now), and it might represent the first U.S. IPO from a cardiac imaging AI startup.

• Orchestra Adds $70M: Orchestra BioMed raised $70M from Ligand Pharmaceuticals ($40M) and Medtronic ($30M) to advance its AVIM therapy for hypertension and Virtue SAB therapy for coronary artery disease. Ligand will receive royalties from Orchestra’s future AVIM and Virtue SAB sales, while Medtronic’s funding expands their partnership to develop AVIM-enabled leadless pacemakers. The funding follows solid progress, as Orchestra’s Virtue balloon just landed FDA IDE for U.S. pivotal trials, while AVIM therapy has shown positive trial results and just gained FDA Breakthrough Designation.

• Sanofi Buys Plozasiran Rights in China: Sanofi will pay $130M upfront and up to $265M in regulatory milestones to acquire rights to plozasiran in China from Arrowhead Pharmaceuticals’ Visirna Therapeutics subsidiary. Plozasiran is an investigational RNAi therapeutic for elevated triglycerides and familial chylomicronemia syndrome and has already received Breakthrough Therapy and Priority Review designations from China’s NPMA.

• Radella’s MD-18 Success: Radella Pharmaceuticals announced positive Phase 1b results for its obesity and diabetes treatment, MD-18. The drug was tested in 36 healthy volunteers over 28 days, and achieved 2.7% weight loss with muscle mass preservation, unlike some GLP-1 drugs that cause muscle loss. MD-18 works as a dual-mechanism peptide that targets the PTP1B gene to restore leptin signaling and increase energy expenditure. Encouragingly, the study’s results showed improved cholesterol, insulin sensitivity, and liver markers with minimal side effects.

• Siesta Now, AFib Later? Siestas are a central part of Iberian and even Mediterranean culture, but this centuries old tradition could lead to increased AFib risk. A 15-year study of 21k Spanish university graduates found that long daytime naps (≥30 minutes) increased AFib risk by 62%, while inadequate nighttime sleep (<6 or >8 hours) increased risk by 89% compared to optimal sleep patterns. Participants with both long naps and inadequate nighttime sleep combined ultimately had a threefold higher AFib risk.

• InfoBionic.Ai ECG Patch 510(k): InfoBionic.Ai announced the FDA clearance of its MoMe ARC 1-Lead Patch, a disposable, single-lead add-on to its AI-powered remote cardiac monitoring platform. The lightweight patch enables extended ECG monitoring without hardware swaps or workflow changes, with the goals of streamlining setup for clinicians and boosting comfort and adherence for patients. The MoMe ARC 1-Lead Patch joins InfoBionic.Ai’s original 6-lead configuration, giving the company two distinct ECG options to “meet patients where they are.”

• RPM for Hypertension Control: JACC: Advances published a large study on over 23k Cadence users with hypertension, which found that the startup’s remote patient monitoring services led to significant improvements in blood pressure control. By leveraging Cadence’s smart BP cuff and tech-enabled protocols, clinicians were able to drive a 14/8 mm Hg average reduction in BP over 30 weeks. That represents a 70% relative increase in the number of patients at goal BP at follow-up.

GLS Analysis of Us2.ai’s Fully-Automated Software

Ten years after the first head-to-head comparison of 2D echocardiography, the latest review suggests Us2.ai is among the easiest to use and integrate. Read the study to learn about how Us2.ai’s software requires zero operator input, operates without human intervention, and leads to high agreement with traditional semi-automated speckle- tracking software solutions.

The Benefits of Outsourced Post-Processing

Using an outsourced cardiac image post-processing solution doesn’t have to mean sacrificing control of the results. Discover how PIA’s customizable post-processing workflow can help you get the most out of your images.

Explore Vitrea Advanced Visualization

Discover Canon Medical Healthcare IT’s suite of advanced imaging workflows designed to increase efficiency in cardiovascular imaging, and facilitate the assessment, diagnosis, and treatment of cardiovascular diseases. These cutting-edge tools support the delivery of faster, more accurate care while integrating seamlessly into clinical workflow

The Resource Wire

• Monebo’s Approach to Cardiac Health Monitoring: The heart works day and night, so your cardiac monitoring software should too. Learn about how Monebo’s latest innovation superimposes long-term monitoring results onto a 24-hour circadian cycle scale, creating a comprehensive map of circadian variations.

• New Horizons in Structural Heart: TAVR and TMVR rates are rising rapidly, placing more pressure on interventional planning. Tune into this Circle CVI and Radcliffe Cardiology breakout detailing how to leverage modern CT workflows to produce efficient and accurate pre-procedural plans.

• Vista AI Reduces Patient Backlog: Cardiac MRI is infamous for its complexity and backlogs, but it doesn’t need to be that way. See how Vista Cardiac delivered a 50% reduction in scan time variability, enabling shorter scheduling blocks and eliminating a one-month backlog.

• 5,600 Ways to Improve Your Cardiac Ultrasound Workflow:AI-powered measurements can enhance the way you acquire and interpret cardiac ultrasound. Learn how AI-powered ultrasound can help you overcome everyday limitations in echo. Read Siemens Healthineers’ white paper on how its AI software provides 5,600+ automated measurements to help improve workflow efficiency, consistency, and clinical confidence.

• A Solution for Your Entire Cardiology Service Line: The pace of change in healthcare can be dizzying, creating new and more complex challenges for cardiology departments to overcome. See how Merge Cardio and Merge Hemo can turn those challenges into opportunities for greater workflow efficiency and improved care.

• Discover Innovation in Intervention: Explore how the AGENT™ Drug-Coated Balloon from Boston Scientific is advancing U.S.-based treatment options for patients with coronary artery disease. Rx Only. (Sponsored by Boston Scientific)

The Industry Wire

1. Epic set to launch its own AI scribe at UGM.
2. Trump executive order centralizes grantmaking under political appointees.
3. Lithium found to be a potential key to reversing Alzheimer’s.
4. Clinicians credit Epic’s AI with helping identify missed lung cancer.
5. Trump floats up to 250% tariff on drug imports.
6. How OBBB is reshaping CEO‑CFO collaboration.
7. Google’s healthcare AI makes up body part during live demo.
8. 11 healthcare orgs join TEFCA nationwide data-sharing push.
9. One dead, one injured in Washington ED shooting.
10. Providence to cut 128 jobs in Oregon.

Ryan P. Daly, MD

Cardiology Business

The State of the TAVR Market in 2025

2025 has been a year of many cardiology trends, with one stand out technology capturing much of the spotlight – transcatheter aortic valves. To keep our valves in a row, Cardiac Wire has compiled a breakdown of the top TAVR makers, movers, shakers, and potential future players. 

Starting off with the biggest player, Edwards Lifesciences controls about 60-70% of the U.S. TAVR market and has some of the most proven tech in the segment…

• Edwards markets the balloon-expandable SAPIEN platform, which is the longest‑established TAVR system (FDA-approved since 2011).
• Earlier this year, the FDA approved SAPIEN’s use for lower-risk and asymptomatic patients thanks to positive results from the EARLY TAVR trial.
• Shoring up its TAVR pipeline for AR therapy, Edwards also acquired JenaValve and JC Medical in 2024 (although the FTC is now trying to block JenaValve).

Medtronic isn’t far behind and essentially makes up the remainder of the market, with 30-35% of TAVR procedures worldwide using a Medtronic valve.

• The company’s product line includes the CoreValve / Evolut series (self‑expanding nitinol valves).
• Some studies, like SMART, suggest Medtronic’s valves could lead to better outcomes in patients with smaller aortic annuli.

Abbott doesn’t intend to let TAVR stay a two horse race for long, and is working on gaining regulatory approval for its own devices.

• Abbott currently produces the Navitor TAVR system (successor to its older Portico), which is in active clinical trials including the ENVISION pivotal study.

Boston Scientific was a TAVR player up until earlier this year when it quietly discontinued its Acurate product line due to unfavorable trial results and potential stroke risks.

So who is left to challenge Edwards and Medtronic for the TAVR throne? 

• Anteris Technologies – Anteris’ balloon-expandable DurAVR THV system looks and works like a human valve (all other TAVRs have three fixed leaflets), and claims calcification benefits.
• JenaValve Technology – Originally Chinese but facing acquisition from Edwards, the JenaValve Trilogy system is undergoing FDA trials for aortic regurgitation and might allow more complex aortic access methods.
• JC Medical – Now also owned by Edwards outside of China, the J‑Valve system is used for both AS/regurgitation and has multiple trials underway.
• Meril Life Sciences – Developer of the Myval TAVR system, India’s first homegrown THV, which launched commercially in India and was CE‑marked in 2019.

The Takeaway

TAVR is certainly here to stay, and while it’s been dominated by two companies for most of its short history, the competition could just be getting started.

Personalized Plaque Analysis Now With Medicare Coverage

Heartflow’s Plaque Analysis is now reimbursable thanks to Medicare’s new coverage for AI-enabled plaque analysis of eligible patients with coronary artery disease.

Tempus Receives FDA 510(k) Clearance for Tempus ECG-Low EF

Tempus announces the expansion of its Tempus ECG-AI portfolio with Tempus ECG-Low EF, software intended for use to analyze 12-lead ECG recordings and detect signs associated with having a low left ventricular ejection fraction (LVEF less than or equal to 40%) in patients 40 years of age or older at risk of heart failure. It is not intended as a stand-alone diagnostic and positive results may suggest the need for further clinical evaluation. For Full Indications for Use, visit here.

Automated and Intelligent EP Reporting

EP ablation procedures are difficult, but your EP reporting process shouldn’t be. See how GE HealthCare’s Centricity EP Structured Reporting allows for quick, accurate, and complete reporting in as few steps as possible.

The Wire

• Edwards’ TAVR-AR Problem: The FTC just voted 3-0 to block Edwards Lifesciences’ $945M acquisition of JenaValve, arguing that it would wipe out competition if Edwards owned the two most advanced TAVR devices for aortic regurgitation. Edwards made a power move into the TAVR-AR space last summer, acquiring the only two TAVR developers with ongoing U.S.-based AR trials (JenaValve and JC Medical). However, the FTC says the deals would stifle innovation, limit patient access, and raise prices, claims that Edwards and JenaValve plan to fight in court.

• Semaglutide’s Cost-Benefit Disconnect: A JAMA study of 23,500+ adults showed that semaglutide (Ozempic/Wegovy) drives weight and cardiometabolic improvements, but might still lead to higher healthcare spending (even if you exclude the GLP-1’s costs). The study’s semaglutide population shed ~4% of their weight over their 13th to 24th months of treatment, while lowering their blood pressure, cholesterol, and A1c. However, the semaglutide users still had ~$80 higher monthly healthcare costs, calling into question previous claims that GLP-1s “will pay for themselves” by reducing downstream healthcare costs.

• DCB NTAP: Boston Scientific scored a big Medicare win for its AGENT drug-coated balloon, used to treat coronary in-stent restenosis. CMS granted the AGENT DCB a New Technology Add-on Payment, giving hospitals extra reimbursement for eligible inpatient cases starting in October, and joining an outpatient Transitional Pass-Through payment that was effective January 1, 2025.  The AGENT DCB gained FDA approval last year, after over 100k treatments internationally, and the new reimbursements should help drive U.S. adoption.

• Pregabalin’s HF Risks: A new Medicare study suggests older adults taking pregabalin for chronic pain treatment could face higher HF risks than those taking gabapentin. The 246k patient study found that pregabalin users had more HF hospitalizations and emergency visits (18.2 vs 12.5 per 1,000 person-years) and that HF risk was particularly elevated in those with CVD history. Researchers now urge careful CV assessment before prescribing pregabalin to older patients, noting that even small absolute risk increases create healthcare burdens.

• Heartflow Shares Jump 50% in IPO: Shares of cardiac AI company Heartflow jumped 50% on August 8, the first day of trading following the company’s IPO. Heartflow raised $317M by issuing 16.7M shares at $19 each, up sharply from the $215M estimated the week before the IPO. That would provide a significant cash infusion for a company that’s already raised a stunning amount of capital (estimated $927M before now), and it might represent the first U.S. IPO from a cardiac imaging AI startup.

• Orchestra Adds $70M: Orchestra BioMed raised $70M from Ligand Pharmaceuticals ($40M) and Medtronic ($30M) to advance its AVIM therapy for hypertension and Virtue SAB therapy for coronary artery disease. Ligand will receive royalties from Orchestra’s future AVIM and Virtue SAB sales, while Medtronic’s funding expands their partnership to develop AVIM-enabled leadless pacemakers. The funding follows solid progress, as Orchestra’s Virtue balloon just landed FDA IDE for U.S. pivotal trials, while AVIM therapy has shown positive trial results and just gained FDA Breakthrough Designation.

• Sanofi Buys Plozasiran Rights in China: Sanofi will pay $130M upfront and up to $265M in regulatory milestones to acquire rights to plozasiran in China from Arrowhead Pharmaceuticals’ Visirna Therapeutics subsidiary. Plozasiran is an investigational RNAi therapeutic for elevated triglycerides and familial chylomicronemia syndrome and has already received Breakthrough Therapy and Priority Review designations from China’s NPMA.

• Radella’s MD-18 Success: Radella Pharmaceuticals announced positive Phase 1b results for its obesity and diabetes treatment, MD-18. The drug was tested in 36 healthy volunteers over 28 days, and achieved 2.7% weight loss with muscle mass preservation, unlike some GLP-1 drugs that cause muscle loss. MD-18 works as a dual-mechanism peptide that targets the PTP1B gene to restore leptin signaling and increase energy expenditure. Encouragingly, the study’s results showed improved cholesterol, insulin sensitivity, and liver markers with minimal side effects.

• Siesta Now, AFib Later? Siestas are a central part of Iberian and even Mediterranean culture, but this centuries old tradition could lead to increased AFib risk. A 15-year study of 21k Spanish university graduates found that long daytime naps (≥30 minutes) increased AFib risk by 62%, while inadequate nighttime sleep (<6 or >8 hours) increased risk by 89% compared to optimal sleep patterns. Participants with both long naps and inadequate nighttime sleep combined ultimately had a threefold higher AFib risk.

• InfoBionic.Ai ECG Patch 510(k): InfoBionic.Ai announced the FDA clearance of its MoMe ARC 1-Lead Patch, a disposable, single-lead add-on to its AI-powered remote cardiac monitoring platform. The lightweight patch enables extended ECG monitoring without hardware swaps or workflow changes, with the goals of streamlining setup for clinicians and boosting comfort and adherence for patients. The MoMe ARC 1-Lead Patch joins InfoBionic.Ai’s original 6-lead configuration, giving the company two distinct ECG options to “meet patients where they are.”

• RPM for Hypertension Control: JACC: Advances published a large study on over 23k Cadence users with hypertension, which found that the startup’s remote patient monitoring services led to significant improvements in blood pressure control. By leveraging Cadence’s smart BP cuff and tech-enabled protocols, clinicians were able to drive a 14/8 mm Hg average reduction in BP over 30 weeks. That represents a 70% relative increase in the number of patients at goal BP at follow-up.

GLS Analysis of Us2.ai’s Fully-Automated Software

Ten years after the first head-to-head comparison of 2D echocardiography, the latest review suggests Us2.ai is among the easiest to use and integrate. Read the study to learn about how Us2.ai’s software requires zero operator input, operates without human intervention, and leads to high agreement with traditional semi-automated speckle- tracking software solutions.

The Benefits of Outsourced Post-Processing

Using an outsourced cardiac image post-processing solution doesn’t have to mean sacrificing control of the results. Discover how PIA’s customizable post-processing workflow can help you get the most out of your images.

Explore Vitrea Advanced Visualization

Discover Canon Medical Healthcare IT’s suite of advanced imaging workflows designed to increase efficiency in cardiovascular imaging, and facilitate the assessment, diagnosis, and treatment of cardiovascular diseases. These cutting-edge tools support the delivery of faster, more accurate care while integrating seamlessly into clinical workflow

The Resource Wire

• Hope for advanced heart failure patients who do not respond to medical treatments: The HeartMate 3™ LVAD offers proven long-term, life-prolonging therapy for a patient population who otherwise would not be expected to survive beyond 1 year. Clinical outcomes for HeartMate 3 LVAD include >5 years median survival and 67% reduction in HRAE- related mortality.

• Monebo’s Approach to Cardiac Health Monitoring: The heart works day and night, so your cardiac monitoring software should too. Learn about how Monebo’s latest innovation superimposes long-term monitoring results onto a 24-hour circadian cycle scale, creating a comprehensive map of circadian variations.

• New Horizons in Structural Heart: TAVR and TMVR rates are rising rapidly, placing more pressure on interventional planning. Tune into this Circle CVI and Radcliffe Cardiology breakout detailing how to leverage modern CT workflows to produce efficient and accurate pre-procedural plans.

• Vista AI Reduces Patient Backlog: Cardiac MRI is infamous for its complexity and backlogs, but it doesn’t need to be that way. See how Vista Cardiac delivered a 50% reduction in scan time variability, enabling shorter scheduling blocks and eliminating a one-month backlog.

• 5,600 Ways to Improve Your Cardiac Ultrasound Workflow:AI-powered measurements can enhance the way you acquire and interpret cardiac ultrasound. Learn how AI-powered ultrasound can help you overcome everyday limitations in echo. Read Siemens Healthineers’ white paper on how its AI software provides 5,600+ automated measurements to help improve workflow efficiency, consistency, and clinical confidence.

• A Solution for Your Entire Cardiology Service Line: The pace of change in healthcare can be dizzying, creating new and more complex challenges for cardiology departments to overcome. See how Merge Cardio and Merge Hemo can turn those challenges into opportunities for greater workflow efficiency and improved care.

• Discover Innovation in Intervention: Explore how the AGENT™ Drug-Coated Balloon from Boston Scientific is advancing U.S.-based treatment options for patients with coronary artery disease. Rx Only. (Sponsored by Boston Scientific)

The Industry Wire

1. Epic set to launch its own AI scribe at UGM.
2. Trump executive order centralizes grantmaking under political appointees.
3. Lithium found to be a potential key to reversing Alzheimer’s.
4. Clinicians credit Epic’s AI with helping identify missed lung cancer.
5. Trump floats up to 250% tariff on drug imports.
6. How OBBB is reshaping CEO‑CFO collaboration.
7. Google’s healthcare AI makes up body part during live demo.
8. 11 healthcare orgs join TEFCA nationwide data-sharing push.
9. One dead, one injured in Washington ED shooting.
10. Providence to cut 128 jobs in Oregon.

Venk Murthy, MD, PhD on the results of a recent CJC study (covered below).

Every year, over 10 million chest CT scans are done in the U.S. alone, and among them, many asymptomatic patients with enlarged heart chambers are missed. In this Cardiac Wire Show interview, we talked to key opinion leaders about the new technologies becoming available to improve heart chamber screening, such as AutoChamber from HeartLung Technologies.

Cardiovascular Disease

The Impact of Physical Activity Before and After CV Events

A long-term analysis of the CARDIA study revealed that moderate-to-vigorous physical activity steadily declines from young adulthood through midlife, but patients destined to develop cardiovascular disease experience rapid activity decreases more than a decade before their first event.

• Studies have shown that moderate-to-vigorous physical activity (MVPA) is critical for both preventing and managing cardiovascular disease.
• To help stave off CVD, guidelines recommend 150 minutes per week of MVPA.
• However, previous research focused on short-term activity patterns rather than lifelong impact on cardiac events.

Collecting data over 37 years, researchers tracked ~3k participants from young adulthood to middle age and paired each individual with a matched control partner, finding that…

• Patients who eventually developed CVD, began decreasing their physical activity levels roughly 12 years before their cardiac events.
• Activity decline accelerated sharply within 2 years before their first cardiovascular event.
• Post-CVD, patients remained 78% more likely to maintain low activity levels compared to matched controls.
• Heart failure patients showed the steepest pre-event declines and consistently low post-event activity.

Researchers also identified striking demographic disparities that persisted throughout the entire study, even after adjusting for pre-CVD activity levels…

• Black women consistently reported the lowest MVPA levels across all age groups.
• Black women also faced the highest risk of low post-CVD activity (OR: 4.52).
• Black men experienced more sustained activity decline compared to other groups.

The Takeaway

This 37-year study reveals that CVD casts a long shadow, with physical activity decline beginning more than a decade before clinical events manifest. Even more sobering is the fact that post-CV-event activity gaps suggest traditional cardiac rehabilitation may not be enough for long-term recovery. In other words, don’t wait till it’s broken to fix it.

GLS Analysis of Us2.ai’s Fully-Automated Software

Ten years after the first head-to-head comparison of 2D echocardiography, the latest review suggests Us2.ai is among the easiest to use and integrate. Read the study to learn about how Us2.ai’s software requires zero operator input, operates without human intervention, and leads to high agreement with traditional semi-automated speckle- tracking software solutions.

Explore Vitrea Advanced Visualization

Discover Canon Medical Healthcare IT’s suite of advanced imaging workflows designed to increase efficiency in cardiovascular imaging, and facilitate the assessment, diagnosis, and treatment of cardiovascular diseases. These cutting-edge tools support the delivery of faster, more accurate care while integrating seamlessly into clinical workflow

Addressing Coronary Artery Disease

Learn how the AGENT™ Drug-Coated Balloon provides a new treatment option for in-stent restenosis in the U.S. Rx Only. (Sponsored by Boston Scientific)

The Wire

• Ultromics’ Series C: Ultromics raised $55M in Series C funding to scale its FDA-cleared AI technology that detects heart failure from routine echocardiograms. The EchoGo platform identifies hard-to-diagnose conditions like HFpEF and cardiac amyloidosis, improving HFpEF detection by 73.6% compared to standard methods. With up to 64% of heart failure cases going undiagnosed and costs projected to reach $70B by 2030, Ultromics’ Medicare-reimbursed solution addresses a critical diagnostic gap.

• Cardiosense’s CardioTag Cleared: Cardiosense received FDA 510(k) clearance for CardioTag, the first multimodal wearable sensor capturing ECG, PPG, and seismocardiogram signals simultaneously. The device measures cardiac mechanics and blood flow beyond traditional rhythm monitoring, accurately assessing cardiac timing intervals like left ventricular ejection time. Cardiosense plans to pair CardioTag with AI algorithms, including their FDA Breakthrough Device-designated pulmonary capillary wedge pressure algorithm that matches implantable sensor accuracy for advanced heart failure management across care settings.

• COVID or Flu in CV Outcomes: A new study in CJC suggests there might be a closer cardiovascular link between the flu and COVID-19 than previously thought. Researchers retrospectively studied 34k hospitalized patients and found similar rates of elevated cardiac biomarkers between both flu and COVID infections, such as troponin elevation (~40% of patients) and natriuretic peptides (72-82%). The study also uncovered that new clinical cardiac diagnoses were rare and similar between groups (for example, HF: ~2.5%, AFib: 3-5%).

• You Are What You Drink: Researchers now believe your refreshment of choice could significantly impact your CVD risk depending on how much sugar is in it. To test this, a recent study out of China developed a “healthy beverage score” (HBS) where coffee, tea, and low-fat milk led to higher scores while sugar-sweetened and artificially sweetened drinks led to lower ones. The study then examined ~9k adults’ beverage consumption patterns and found that participants with low HBS had increased CVD and all-cause mortality risks, regardless of age, sex, smoking status, and other factors.

• But You’re Not What You Smoke: In the same vein, another study found that smoking cannabis might not increase a person’s risk of CVD unlike previously thought. The study examined 4.2k veterans (ages 66-68) with coronary artery disease and found that those who reported smoking cannabis in the past 30 days showed no increased risk of cardiovascular death, stroke, or heart attack compared to those who didn’t over a 3.3 year follow-up (aHR: 0.87).

• Sulfonyureas Increase CV Risk: Adding to the complications between T2D and CVD, a recent JAMA study found that diabetes patients on metformin faced higher CVD risks while taking sulfonylureas compared to DPP4is. Researchers studied 48k T2D patients on metformin and found five-year MACE rates for patients taking DPP4 inhibitors were 8.1%, which was lower than sulfonylureas like glyburide (8.4%), glimepiride (8.6%), and glipizide (9.1%). Despite known cardiovascular concerns, glipizide remains widely used due to its low cost (~$50 annually).

• Post-TAVR Stroke Higher in Women: TAVR outcomes might be different between men and women, especially when it comes to stroke. A study of nearly 380k TAVR patients from 2016-2021 found that women had significantly higher stroke rates than men (2.31% vs 1.69%). The primary driver of this disparity was disabling strokes occurring in 1.61% of women versus 1.02% of men. Researchers suggest clinicians counsel female patients about heightened stroke risk and consider tailored strategies like embolic protection devices to improve outcomes.

• DNA Methylation Impacts CVD: Strengthening the association between genetics and CVD, a new Circulation study suggests DNA methylation could play a big role in CVD risk. Researchers analyzed DNA methylation patterns across 5 diverse cohorts using the AHA’s Life’s Essential 8 score and identified 609 methylation sites linked to cardiovascular health. The most important DNA sites were those that coded for inflammatory pathways leading to strong associations with stroke (29-fold) and ischemic heart disease (21-fold).

• How Old Are Your Veins? Researchers have developed an Aortic Vascular Age Index (AVAI) using 3D imaging to quantify vascular aging, revealing that the heart is directly impacted by how “old” our vasculature is. After creating the index, researchers studied 63k patients and found that early aortic aging was associated with adverse cardiac remodeling, including increased left ventricular mass and wall thickness. Beyond this, a patient’s AVAI showed high heritability (40%) with 54 genes identified, mostly involving fibrillin-1 and elastin genes.

• Junctophilin’s Role in Cardiac Remodeling: According to a Circulation study, there could be a specific membrane protein that is involved in fibrosis following MI. Using mice models, researchers uncovered that junctophilin-2 (Jph2) is the only junctophilin expressed in cardiac fibroblasts (CFs) and increases after myocardial infarction. Fibroblast-specific Jph2 mice showed worse cardiac remodeling post-MI, including decreased CF activation, enhanced proliferation, systolic dysfunction, and impaired angiogenesis. On the other hand, mice with Jph2-deficient CFs showed impaired activation, reduced extracellular matrix production, and decreased VEGF expression.

• Lp(a) Helps Predict ASCVD: Revisiting the debate around Lp(a)’s predictive abilities, a UK Biobank study suggests the molecule significantly predicts extracoronary ASCVD. Over 13.6 years of follow-up, patients with a higher Lp(a) concentration faced an increased risk of peripheral artery disease (HR 1.18 per 75 nmol/L) and carotid stenosis (HR 1.17). Among those with existing PAD, high Lp(a) also increased major adverse limb events by 57%.

Identify and Treat Cardiovascular Disease

Complex care pathways make getting patients to the next step a challenge. See how Tempus Next, an AI enabled care pathway platform, helps providers identify and reduce under treatment in cardiovascular disease by adding an intelligent layer onto their routinely generated EHR data.

An All-in-One Coronary Care Solution

See how HeartFlow ONE is transforming precision heart care as the first all-in-one CCTA pathway, combining FFRCT, stenosis, and plaque analysis in a single workflow.

PIA Medical Processes It All

Need an analysis like calcium scoring, strain or even FFR? PIA Medical began as a Core Lab and can handle creative cardiac research and clinical trials along with the full breadth of clinical analyses available today.

The Resource Wire

• Configure Your PCI Study: See for yourself how cardiac imagers use GE HealthCare’s Centricity Cardio Enterprise Universal Viewer to do their PCI studies, including configurable viewport setup and side-by-side comparisons.

• Assessing CAD with Circle CVI: Did you know that Circle CVI offers a suite of cardiac CT tools for the assessment of coronary artery disease? See how Circle combines heart function segmentation, automated plaque analysis, CAC scoring, reporting, and viewing in a single dedicated Cardiac CT package.

• CMR Access Is Broken—Here’s How to Fix It​: Cardiac MRI is one of the most powerful tools for diagnosing heart disease, yet it’s still out of reach for many patients. Download Vista AI’s new infographic to see what’s holding CMR adoption back—and how AI and automation can help make gold-standard imaging more accessible than ever.

• Your Cardiology Data is Valuable. Put it To Work. See how one major Midwest health system’s decision to implement Merge Cardio transformed physician and staff workflows, improved data entry speed and accuracy, and increased cost savings.

• Monebo’s Approach to Cardiac Health Monitoring: The heart works day and night, so your cardiac monitoring software should too. Learn about how Monebo’s latest innovation superimposes long-term monitoring results onto a 24-hour circadian cycle scale, creating a comprehensive map of circadian variations.

• 5,600 Ways to Improve Your Cardiac Ultrasound Workflow: AI-powered measurements can enhance the way you acquire and interpret cardiac ultrasound. Learn how AI-powered ultrasound can help you overcome everyday limitations in echo. Read Siemens Healthineers’ white paper on how its AI software provides 5,600+ automated measurements to help improve workflow efficiency, consistency, and clinical confidence.

The Industry Wire

1. New T1D treatments could target the brain.
2. Major healthcare equipment firm on brink of failure.
3. UnitedHealth Group to replace CFO.
4. FDA requires labels to clarify opioid risks.
5. Trump admin to pilot 340B rebate model next year.
6. Cigna beats investor expectations on Evernorth growth.
7. >50% of healthcare orgs attacked with ransomware last year.
8. Trump admin also launches health data sharing initiative.
9. CMS finalizes 2.6% hospital pay bump for FY2026.
10. Medicaid cuts drive hospitals’ efficiency overhaul.

Venk Murthy, MD, PhD on the results of a recent CJC study (covered below).

Every year, over 10 million chest CT scans are done in the U.S. alone, and among them, many asymptomatic patients with enlarged heart chambers are missed. In this Cardiac Wire Show interview, we talked to key opinion leaders about the new technologies becoming available to improve heart chamber screening, such as AutoChamber from HeartLung Technologies.

Cardiovascular Disease

The Impact of Physical Activity Before and After CV Events

A long-term analysis of the CARDIA study revealed that moderate-to-vigorous physical activity steadily declines from young adulthood through midlife, but patients destined to develop cardiovascular disease experience rapid activity decreases more than a decade before their first event.

• Studies have shown that moderate-to-vigorous physical activity (MVPA) is critical for both preventing and managing cardiovascular disease.
• To help stave off CVD, guidelines recommend 150 minutes per week of MVPA.
• However, previous research focused on short-term activity patterns rather than lifelong impact on cardiac events.

Collecting data over 37 years, researchers tracked ~3k participants from young adulthood to middle age and paired each individual with a matched control partner, finding that…

• Patients who eventually developed CVD, began decreasing their physical activity levels roughly 12 years before their cardiac events.
• Activity decline accelerated sharply within 2 years before their first cardiovascular event.
• Post-CVD, patients remained 78% more likely to maintain low activity levels compared to matched controls.
• Heart failure patients showed the steepest pre-event declines and consistently low post-event activity.

Researchers also identified striking demographic disparities that persisted throughout the entire study, even after adjusting for pre-CVD activity levels…

• Black women consistently reported the lowest MVPA levels across all age groups.
• Black women also faced the highest risk of low post-CVD activity (OR: 4.52).
• Black men experienced more sustained activity decline compared to other groups.

The Takeaway

This 37-year study reveals that CVD casts a long shadow, with physical activity decline beginning more than a decade before clinical events manifest. Even more sobering is the fact that post-CV-event activity gaps suggest traditional cardiac rehabilitation may not be enough for long-term recovery. In other words, don’t wait till it’s broken to fix it.

GLS Analysis of Us2.ai’s Fully-Automated Software

Ten years after the first head-to-head comparison of 2D echocardiography, the latest review suggests Us2.ai is among the easiest to use and integrate. Read the study to learn about how Us2.ai’s software requires zero operator input, operates without human intervention, and leads to high agreement with traditional semi-automated speckle- tracking software solutions.

Explore Vitrea Advanced Visualization

Discover Canon Medical Healthcare IT’s suite of advanced imaging workflows designed to increase efficiency in cardiovascular imaging, and facilitate the assessment, diagnosis, and treatment of cardiovascular diseases. These cutting-edge tools support the delivery of faster, more accurate care while integrating seamlessly into clinical workflow

Addressing Coronary Artery Disease

Learn how the AGENT™ Drug-Coated Balloon provides a new treatment option for in-stent restenosis in the U.S. Rx Only. (Sponsored by Boston Scientific)

The Wire

• Ultromics’ Series C: Ultromics raised $55M in Series C funding to scale its FDA-cleared AI technology that detects heart failure from routine echocardiograms. The EchoGo platform identifies hard-to-diagnose conditions like HFpEF and cardiac amyloidosis, improving HFpEF detection by 73.6% compared to standard methods. With up to 64% of heart failure cases going undiagnosed and costs projected to reach $70B by 2030, Ultromics’ Medicare-reimbursed solution addresses a critical diagnostic gap.

• Cardiosense’s CardioTag Cleared: Cardiosense received FDA 510(k) clearance for CardioTag, the first multimodal wearable sensor capturing ECG, PPG, and seismocardiogram signals simultaneously. The device measures cardiac mechanics and blood flow beyond traditional rhythm monitoring, accurately assessing cardiac timing intervals like left ventricular ejection time. Cardiosense plans to pair CardioTag with AI algorithms, including their FDA Breakthrough Device-designated pulmonary capillary wedge pressure algorithm that matches implantable sensor accuracy for advanced heart failure management across care settings.

• COVID or Flu in CV Outcomes: A new study in CJC suggests there might be a closer cardiovascular link between the flu and COVID-19 than previously thought. Researchers retrospectively studied 34k hospitalized patients and found similar rates of elevated cardiac biomarkers between both flu and COVID infections, such as troponin elevation (~40% of patients) and natriuretic peptides (72-82%). The study also uncovered that new clinical cardiac diagnoses were rare and similar between groups (for example, HF: ~2.5%, AFib: 3-5%).

• You Are What You Drink: Researchers now believe your refreshment of choice could significantly impact your CVD risk depending on how much sugar is in it. To test this, a recent study out of China developed a “healthy beverage score” (HBS) where coffee, tea, and low-fat milk led to higher scores while sugar-sweetened and artificially sweetened drinks led to lower ones. The study then examined ~9k adults’ beverage consumption patterns and found that participants with low HBS had increased CVD and all-cause mortality risks, regardless of age, sex, smoking status, and other factors.

• But You’re Not What You Smoke: In the same vein, another study found that smoking cannabis might not increase a person’s risk of CVD unlike previously thought. The study examined 4.2k veterans (ages 66-68) with coronary artery disease and found that those who reported smoking cannabis in the past 30 days showed no increased risk of cardiovascular death, stroke, or heart attack compared to those who didn’t over a 3.3 year follow-up (aHR: 0.87).

• Sulfonyureas Increase CV Risk: Adding to the complications between T2D and CVD, a recent JAMA study found that diabetes patients on metformin faced higher CVD risks while taking sulfonylureas compared to DPP4is. Researchers studied 48k T2D patients on metformin and found five-year MACE rates for patients taking DPP4 inhibitors were 8.1%, which was lower than sulfonylureas like glyburide (8.4%), glimepiride (8.6%), and glipizide (9.1%). Despite known cardiovascular concerns, glipizide remains widely used due to its low cost (~$50 annually).

• Post-TAVR Stroke Higher in Women: TAVR outcomes might be different between men and women, especially when it comes to stroke. A study of nearly 380k TAVR patients from 2016-2021 found that women had significantly higher stroke rates than men (2.31% vs 1.69%). The primary driver of this disparity was disabling strokes occurring in 1.61% of women versus 1.02% of men. Researchers suggest clinicians counsel female patients about heightened stroke risk and consider tailored strategies like embolic protection devices to improve outcomes.

• DNA Methylation Impacts CVD: Strengthening the association between genetics and CVD, a new Circulation study suggests DNA methylation could play a big role in CVD risk. Researchers analyzed DNA methylation patterns across 5 diverse cohorts using the AHA’s Life’s Essential 8 score and identified 609 methylation sites linked to cardiovascular health. The most important DNA sites were those that coded for inflammatory pathways leading to strong associations with stroke (29-fold) and ischemic heart disease (21-fold).

• How Old Are Your Veins? Researchers have developed an Aortic Vascular Age Index (AVAI) using 3D imaging to quantify vascular aging, revealing that the heart is directly impacted by how “old” our vasculature is. After creating the index, researchers studied 63k patients and found that early aortic aging was associated with adverse cardiac remodeling, including increased left ventricular mass and wall thickness. Beyond this, a patient’s AVAI showed high heritability (40%) with 54 genes identified, mostly involving fibrillin-1 and elastin genes.

• Junctophilin’s Role in Cardiac Remodeling: According to a Circulation study, there could be a specific membrane protein that is involved in fibrosis following MI. Using mice models, researchers uncovered that junctophilin-2 (Jph2) is the only junctophilin expressed in cardiac fibroblasts (CFs) and increases after myocardial infarction. Fibroblast-specific Jph2 mice showed worse cardiac remodeling post-MI, including decreased CF activation, enhanced proliferation, systolic dysfunction, and impaired angiogenesis. On the other hand, mice with Jph2-deficient CFs showed impaired activation, reduced extracellular matrix production, and decreased VEGF expression.

• Lp(a) Helps Predict ASCVD: Revisiting the debate around Lp(a)’s predictive abilities, a UK Biobank study suggests the molecule significantly predicts extracoronary ASCVD. Over 13.6 years of follow-up, patients with a higher Lp(a) concentration faced an increased risk of peripheral artery disease (HR 1.18 per 75 nmol/L) and carotid stenosis (HR 1.17). Among those with existing PAD, high Lp(a) also increased major adverse limb events by 57%.

Identify and Treat Cardiovascular Disease

Complex care pathways make getting patients to the next step a challenge. See how Tempus Next, an AI enabled care pathway platform, helps providers identify and reduce under treatment in cardiovascular disease by adding an intelligent layer onto their routinely generated EHR data.

An All-in-One Coronary Care Solution

See how HeartFlow ONE is transforming precision heart care as the first all-in-one CCTA pathway, combining FFRCT, stenosis, and plaque analysis in a single workflow.

PIA Medical Processes It All

Need an analysis like calcium scoring, strain or even FFR? PIA Medical began as a Core Lab and can handle creative cardiac research and clinical trials along with the full breadth of clinical analyses available today.

The Resource Wire

• Configure Your PCI Study: See for yourself how cardiac imagers use GE HealthCare’s Centricity Cardio Enterprise Universal Viewer to do their PCI studies, including configurable viewport setup and side-by-side comparisons.

• Assessing CAD with Circle CVI: Did you know that Circle CVI offers a suite of cardiac CT tools for the assessment of coronary artery disease? See how Circle combines heart function segmentation, automated plaque analysis, CAC scoring, reporting, and viewing in a single dedicated Cardiac CT package.

• Hope for advanced heart failure patients who do not respond to medical treatments: The HeartMate 3™ LVAD offers proven long-term, life-prolonging therapy for a patient population who otherwise would not be expected to survive beyond 1 year. Clinical outcomes for HeartMate 3 LVAD include >5 years median survival and 67% reduction in HRAE- related mortality.

• CMR Access Is Broken—Here’s How to Fix It​: Cardiac MRI is one of the most powerful tools for diagnosing heart disease, yet it’s still out of reach for many patients. Download Vista AI’s new infographic to see what’s holding CMR adoption back—and how AI and automation can help make gold-standard imaging more accessible than ever.

• Your Cardiology Data is Valuable. Put it To Work. See how one major Midwest health system’s decision to implement Merge Cardio transformed physician and staff workflows, improved data entry speed and accuracy, and increased cost savings.

• Monebo’s Approach to Cardiac Health Monitoring: The heart works day and night, so your cardiac monitoring software should too. Learn about how Monebo’s latest innovation superimposes long-term monitoring results onto a 24-hour circadian cycle scale, creating a comprehensive map of circadian variations.

• 5,600 Ways to Improve Your Cardiac Ultrasound Workflow: AI-powered measurements can enhance the way you acquire and interpret cardiac ultrasound. Learn how AI-powered ultrasound can help you overcome everyday limitations in echo. Read Siemens Healthineers’ white paper on how its AI software provides 5,600+ automated measurements to help improve workflow efficiency, consistency, and clinical confidence.

The Industry Wire

1. New T1D treatments could target the brain.
2. Major healthcare equipment firm on brink of failure.
3. UnitedHealth Group to replace CFO.
4. FDA requires labels to clarify opioid risks.
5. Trump admin to pilot 340B rebate model next year.
6. Cigna beats investor expectations on Evernorth growth.
7. >50% of healthcare orgs attacked with ransomware last year.
8. Trump admin also launches health data sharing initiative.
9. CMS finalizes 2.6% hospital pay bump for FY2026.
10. Medicaid cuts drive hospitals’ efficiency overhaul.

Joseph Marine, MD.

The cardiac CT space is booming with new software that quantifies and characterizes plaque, but only one uncovers plaque morphology based on ground-truth histology. Watch this episode of The Cardiac Wire Show to learn from Dr. Robert Pelberg, MD and Dr. Mark Berlacher, MD about Elucid’s non-invasive plaque analysis.

Cardiology Pharmaceuticals

AstraZeneca’s Anselamimab Comes Up Short in Phase 3 Trial

In a setback to one of its rarer disease pipelines, AstraZeneca’s amyloidosis antibody, anselamimab, failed to significantly reduce all-cause mortality and CV hospitalizations in the CARES Phase 3 trial’s overall patient population.

• AL amyloidosis is a rare disease (only about 70k people worldwide) where misfolded light chain proteins form toxic amyloid deposits in the heart and kidneys.
• These deposits cause progressive organ damage and dysfunction, often leading to death from cardiac failure.
• Current treatments focus on plasma cell dyscrasia but don’t address existing amyloid deposits that damage organs.

 The CARES clinical program was the largest prospective cardiac AL amyloidosis investigation to date, enrolling 406 patients to test whether anselamimab could reduce all-cause mortality and cardiovascular hospitalizations when added to standard background therapy.

• All patients had Mayo disease stages IIIa (281 patients) and IIIb (125 patients), which are considered the most advanced.
• Treatment with anselamimab was administered weekly for 4 weeks, then every 2 weeks for 18 months but led to no significant improvements in mortality or hospitalization rates.

However, despite the overall trial not reaching statistical significance, researchers identified meaningful clinical benefits in a “prespecified patient subgroup” that experienced extended survival and fewer cardiovascular hospitalizations compared to placebo.

• The subgroup analysis was planned before the trial began, lending credibility to the findings.
• That said, AstraZeneca has not released any description or data regarding this patient subgroup.

So what do these mixed results mean for AstraZeneca? 

• While anselamimab didn’t achieve broad efficacy across all patients, the meaningful benefits seen in a defined subgroup suggest it could still fill a critical treatment gap.
• AstraZeneca didn’t reveal its plans for anselamimab, but will still share this data with global health authorities and present it at a coming medical meeting.

The Takeaway

It’s never easy when a drug fails to meet expectations in later stage trials and while we don’t have the full data yet, AstraZeneca’s update makes it seem like anselamimab’s scope could be even more limited than intended. Hopefully we’ll learn more about the patient subgroup that significantly benefitted from the drug in case AZ pivots its efforts to them.

Vista AI Grows CMR Volume

Are your patients waiting weeks or months for cardiac MRIs? See Brigham and Women’s Hospital’s real-world results showing how Vista AI’s software for automated MRI scanning led to 50% more scan slots, without adding more scanners or staff.

Streamline Your Cardiology Imaging Workflows

See how cardiologists and their teams can streamline imaging workflows to make their cardiovascular service line more efficient, cost-effective, and patient-centered, using Merge’s cardiology solutions.

Discover The Monebo Advantage

Need complex ECG monitoring algorithms for use in a variety of applications? Here are just a few reasons why companies across the healthcare spectrum rely on Monebo to power their ECG monitoring and analysis.

The Wire

• GDMT Improves HF LEF: A JACC study of 28k patients with HFrEF suggests GDMT helped almost a third of patients reach an improved ejection fraction (HFimpEF) within 12 months, with some exceptions. Despite these improvements, HFimpEF patients had worsening HF rates of 17.4 per 100 person-years and death rates of 5.7 per 100 person-years, but this was still lower than persistent HFrEF patients. The study also found that GDMT use decreased after HFimpEF diagnosis, suggesting need for continued treatment optimization.

• Vektor vMap Hits 2k Procedures: Vektor Medical announced that its FDA-cleared vMap system reached 2,000 procedures in the United States, demonstrating increasing adoption by electrophysiologists for uncovering AFib across the heart. The AI-powered system localizes arrhythmias in all four heart chambers within one minute, helping reduce procedure times and improve patient outcomes. Clinical studies show vMap can decrease fluoroscopy time and potentially reduce repeat interventions.

• Roche Cuts CT-173 Development: Roche discontinued CT-173, an obesity drug from its $2.7B Carmot acquisition, despite previously touting its potential to avoid the usual GLP-1 weight loss plateaus. The company cited lack of competitiveness and developability and also axed four unrelated phase 1 programs including three solid tumor assets and an eye disease candidate. The cuts are part of portfolio reprioritization towards high-value areas like other obesity solutions and Alzheimer’s.

• USPSTF On the Chopping Block? HHS Secretary Robert F. Kennedy, Jr. is reportedly mulling changes to the USPSTF that could include firing all 16 members of the advisory panel and replacing them with his own picks. USPSTF consists of clinicians who volunteer for the panel to provide guidance on preventive care issues like screening, and payors must cover USPSTF-recommended exams without requiring patient co-pays. Medical groups like the AMA have gone on record opposing any change to the current USPSTF panel.

• Stereotaxis’ FDA Clearance: Stereotaxis received FDA 510(k) clearance for its Magic Sweep navigation device, touted as the world’s first robotically navigated high-density EP mapping catheter. The 20-electrode device enables rapid, detailed heart chamber mapping for cardiac ablation procedures and integrates with Stereotaxis’ robotic systems for precise navigation. This marks Stereotaxis’s first FDA clearance for an interventional catheter in nearly 20 years, and comes shortly after the company raised $12.5M through institutional investors and an industry partner.

• Dapagliflozin + Spironolactone = Better HF: Combining dapagliflozin and spironolactone for treating HF could be more effective than dapagliflozin alone, but not without side effects. A randomized crossover trial of 108 HF patients compared a dapagliflozin/spironolactone combination to dapagliflozin alone and found the combo reduced NT-proBNP levels by 11% more while lowering SBP (-5.2 mmHg) and urinary albumin over 12-weeks. However, the combo decreased kidney function (eGFR: -6.4 mL/min/1.73m²) and increased potassium levels.

• Rocket Begins Layoffs, Pivots to CV Pipeline: Rocket Pharmaceuticals will lay off 30% of its workforce and narrow its focus to cardiovascular programs after a patient death in its Danon disease gene therapy trial prompted an FDA hold. Now the company plans to prioritize its AAV platform and cardiovascular assets while deprioritizing hematology programs. Rocket believes the restructuring will extend its cash runway into Q2 2027, while delaying FDA approval timelines for other drugs.

• AHA Ventures Backs Auxira: Partnering with the AHA’s venture arm, Auxira Health plans to expand cardiology practices’ access to its white-label telehealth staffing solution. The startup virtually embeds clinical support teams (APPs, nurses, medical assistants) into existing workflows, handling lower-acuity tasks to help cardiologists focus on complex care. Auxira’s current results include 37% increased capacity, 14% improved patient satisfaction, and 35% reduced after-hours work.

• Get Those Steps In: New research published in The Lancet Public Health seems to support RFK’s mission of strapping wearables to everyone’s wrist. The systematic review of 57 studies found that 7,000 daily steps is the magic number for health outcomes, with participants that reached that threshold seeing a significantly lower risk of all-cause mortality (-47%), dementia (-38%), cardiovascular disease (-25%), and type 2 diabetes (-14%).

• USG Cracks Down on Ultra-Processing: The HHS, FDA, and USDA launched an initiative to reduce American consumption of ultra-processed foods, which research links to cardiovascular disease, type 2 diabetes, obesity, and other health conditions. The first phase of the initiative involves creating a uniform definition to guide researchers and policymakers and considers ultra-processed foods anything from packaged snacks, to sugary drinks, cereals, and frozen dinners that undergo industrial processing.

• The Best Cardiology Hospitals: NYU Langone claimed the No. 1 spot for cardiology, heart surgery, and vascular surgery in U.S. News & World Report’s Best Hospitals rankings, ending Cleveland Clinic’s five-year reign. Mount Sinai Hospital ranked No. 2, with Cleveland Clinic dropping to No. 3. The rankings analyzed data from nearly 4,500 facilities and are weighted based on patient outcomes (45%), hospital structure (35%), expert opinion surveys (12%), patient experience (5%), and transparency initiatives (3%).

Siemens Healthineers ACUSON Origin Ultrasound System is Redefining CVUS

ACUSON Origin meets the demands of today’s cardiovascular care with AI-powered efficiency across adult and pediatric echo, vascular, structural heart, and EP. Streamlined workflows, intuitive walk-up usability, and advanced ergonomics empower clinicians to deliver confident, high-quality care—supporting a wide range of complex cases and clinical applications.

Redefining Percutaneous Coronary Intervention

Learn about the AGENT™ Drug-Coated Balloon from Boston Scientific and how this technology is expanding the treatment options for patients with in-stent restenosis in the U.S. Rx only. (Sponsored by Boston Scientific)

The Resource Wire

• Tempus Receives FDA 510(k) Clearance for Tempus ECG-Low EF: Tempus announces the expansion of its Tempus ECG-AI portfolio with Tempus ECG-Low EF, software intended for use to analyze 12-lead ECG recordings and detect signs associated with having a low left ventricular ejection fraction (LVEF less than or equal to 40%) in patients 40 years of age or older at risk of heart failure. It is not intended as a stand-alone diagnostic and positive results may suggest the need for further clinical evaluation. For Full Indications for Use, visit here.

• Explore Vitrea Advanced Visualization: Discover Canon Medical Healthcare IT’s suite of advanced imaging workflows designed to increase efficiency in cardiovascular imaging, and facilitate the assessment, diagnosis, and treatment of cardiovascular diseases. These cutting-edge tools support the delivery of faster, more accurate care while integrating seamlessly into clinical workflows.

• Patient Attitudes Towards Us2.ai’s AI-Echo: The medical imaging field is rapidly accepting AI, but how are patients feeling about the shift? Get the scoop on patients’ positive opinions toward Us2.ai’s software that supports task shifting from conventional echo to AI-echo.

• Personalized Plaque Analysis Now With Medicare Coverage: Heartflow’s Plaque Analysis is now reimbursable thanks to Medicare’s new coverage for AI-enabled plaque analysis of eligible patients with coronary artery disease.

• A Single Cardiac Service Line Platform: Transitioning across multiple imaging platforms is a daily reality for many cardiologists, but it doesn’t have to be. See how three leading cardiac imagers are leveraging Circle CVI’s unified multi-modal software across their diverse caseloads, without switching to other platforms.

• PIA’s Post-Processing Solution: Advanced cardiac imaging often calls for a time-consuming post-processing step, requiring costly software, hardware, and training. See how PIA provides this post-processing at lower cost, improved consistency, and greater efficiency. 

• Automate Your Echo Reporting: It’s a good feeling when your echo report is already 83% complete before you even sit down to work on it. See how Centricity Cardio Enterprise’s echo automation features make this “good feeling” an everyday occurrence in this quick GE HealthCare demo video.

The Industry Wire

1. Humana raises outlook as it navigates high medical costs.
2. Tariffs on European medicines could cost drugmakers billions.
3. Elevance names former Cencora CEO to board.
4. White House, CMS launch initiative to spur use of digital health.
5. US Senate confirms Susan Monarez as CDC director.
6. FDA’s top vaccine official, Vinay Prasad, out after 3 months.
7. Medicare Part D premiums likely to increase next year.
8. Astrana Health CEO on value-based care letdowns.
9. UVM Health lays off dozens.
10. How hospital ‘harm events’ slip through the cracks.

Joseph Marine, MD.

The cardiac CT space is booming with new software that quantifies and characterizes plaque, but only one uncovers plaque morphology based on ground-truth histology. Watch this episode of The Cardiac Wire Show to learn from Dr. Robert Pelberg, MD and Dr. Mark Berlacher, MD about Elucid’s non-invasive plaque analysis.

Cardiology Pharmaceuticals

AstraZeneca’s Anselamimab Comes Up Short in Phase 3 Trial

In a setback to one of its rarer disease pipelines, AstraZeneca’s amyloidosis antibody, anselamimab, failed to significantly reduce all-cause mortality and CV hospitalizations in the CARES Phase 3 trial’s overall patient population.

• AL amyloidosis is a rare disease (only about 70k people worldwide) where misfolded light chain proteins form toxic amyloid deposits in the heart and kidneys.
• These deposits cause progressive organ damage and dysfunction, often leading to death from cardiac failure.
• Current treatments focus on plasma cell dyscrasia but don’t address existing amyloid deposits that damage organs.

 The CARES clinical program was the largest prospective cardiac AL amyloidosis investigation to date, enrolling 406 patients to test whether anselamimab could reduce all-cause mortality and cardiovascular hospitalizations when added to standard background therapy.

• All patients had Mayo disease stages IIIa (281 patients) and IIIb (125 patients), which are considered the most advanced.
• Treatment with anselamimab was administered weekly for 4 weeks, then every 2 weeks for 18 months but led to no significant improvements in mortality or hospitalization rates.

However, despite the overall trial not reaching statistical significance, researchers identified meaningful clinical benefits in a “prespecified patient subgroup” that experienced extended survival and fewer cardiovascular hospitalizations compared to placebo.

• The subgroup analysis was planned before the trial began, lending credibility to the findings.
• That said, AstraZeneca has not released any description or data regarding this patient subgroup.

So what do these mixed results mean for AstraZeneca? 

• While anselamimab didn’t achieve broad efficacy across all patients, the meaningful benefits seen in a defined subgroup suggest it could still fill a critical treatment gap.
• AstraZeneca didn’t reveal its plans for anselamimab, but will still share this data with global health authorities and present it at a coming medical meeting.

The Takeaway

It’s never easy when a drug fails to meet expectations in later stage trials and while we don’t have the full data yet, AstraZeneca’s update makes it seem like anselamimab’s scope could be even more limited than intended. Hopefully we’ll learn more about the patient subgroup that significantly benefitted from the drug in case AZ pivots its efforts to them.

Vista AI Grows CMR Volume

Are your patients waiting weeks or months for cardiac MRIs? See Brigham and Women’s Hospital’s real-world results showing how Vista AI’s software for automated MRI scanning led to 50% more scan slots, without adding more scanners or staff.

Streamline Your Cardiology Imaging Workflows

See how cardiologists and their teams can streamline imaging workflows to make their cardiovascular service line more efficient, cost-effective, and patient-centered, using Merge’s cardiology solutions.

Discover The Monebo Advantage

Need complex ECG monitoring algorithms for use in a variety of applications? Here are just a few reasons why companies across the healthcare spectrum rely on Monebo to power their ECG monitoring and analysis.

The Wire

• GDMT Improves HF LEF: A JACC study of 28k patients with HFrEF suggests GDMT helped almost a third of patients reach an improved ejection fraction (HFimpEF) within 12 months, with some exceptions. Despite these improvements, HFimpEF patients had worsening HF rates of 17.4 per 100 person-years and death rates of 5.7 per 100 person-years, but this was still lower than persistent HFrEF patients. The study also found that GDMT use decreased after HFimpEF diagnosis, suggesting need for continued treatment optimization.

• Vektor vMap Hits 2k Procedures: Vektor Medical announced that its FDA-cleared vMap system reached 2,000 procedures in the United States, demonstrating increasing adoption by electrophysiologists for uncovering AFib across the heart. The AI-powered system localizes arrhythmias in all four heart chambers within one minute, helping reduce procedure times and improve patient outcomes. Clinical studies show vMap can decrease fluoroscopy time and potentially reduce repeat interventions.

• Roche Cuts CT-173 Development: Roche discontinued CT-173, an obesity drug from its $2.7B Carmot acquisition, despite previously touting its potential to avoid the usual GLP-1 weight loss plateaus. The company cited lack of competitiveness and developability and also axed four unrelated phase 1 programs including three solid tumor assets and an eye disease candidate. The cuts are part of portfolio reprioritization towards high-value areas like other obesity solutions and Alzheimer’s.

• USPSTF On the Chopping Block? HHS Secretary Robert F. Kennedy, Jr. is reportedly mulling changes to the USPSTF that could include firing all 16 members of the advisory panel and replacing them with his own picks. USPSTF consists of clinicians who volunteer for the panel to provide guidance on preventive care issues like screening, and payors must cover USPSTF-recommended exams without requiring patient co-pays. Medical groups like the AMA have gone on record opposing any change to the current USPSTF panel.

• Stereotaxis’ FDA Clearance: Stereotaxis received FDA 510(k) clearance for its Magic Sweep navigation device, touted as the world’s first robotically navigated high-density EP mapping catheter. The 20-electrode device enables rapid, detailed heart chamber mapping for cardiac ablation procedures and integrates with Stereotaxis’ robotic systems for precise navigation. This marks Stereotaxis’s first FDA clearance for an interventional catheter in nearly 20 years, and comes shortly after the company raised $12.5M through institutional investors and an industry partner.

• Dapagliflozin + Spironolactone = Better HF: Combining dapagliflozin and spironolactone for treating HF could be more effective than dapagliflozin alone, but not without side effects. A randomized crossover trial of 108 HF patients compared a dapagliflozin/spironolactone combination to dapagliflozin alone and found the combo reduced NT-proBNP levels by 11% more while lowering SBP (-5.2 mmHg) and urinary albumin over 12-weeks. However, the combo decreased kidney function (eGFR: -6.4 mL/min/1.73m²) and increased potassium levels.

• Rocket Begins Layoffs, Pivots to CV Pipeline: Rocket Pharmaceuticals will lay off 30% of its workforce and narrow its focus to cardiovascular programs after a patient death in its Danon disease gene therapy trial prompted an FDA hold. Now the company plans to prioritize its AAV platform and cardiovascular assets while deprioritizing hematology programs. Rocket believes the restructuring will extend its cash runway into Q2 2027, while delaying FDA approval timelines for other drugs.

• AHA Ventures Backs Auxira: Partnering with the AHA’s venture arm, Auxira Health plans to expand cardiology practices’ access to its white-label telehealth staffing solution. The startup virtually embeds clinical support teams (APPs, nurses, medical assistants) into existing workflows, handling lower-acuity tasks to help cardiologists focus on complex care. Auxira’s current results include 37% increased capacity, 14% improved patient satisfaction, and 35% reduced after-hours work.

• Get Those Steps In: New research published in The Lancet Public Health seems to support RFK’s mission of strapping wearables to everyone’s wrist. The systematic review of 57 studies found that 7,000 daily steps is the magic number for health outcomes, with participants that reached that threshold seeing a significantly lower risk of all-cause mortality (-47%), dementia (-38%), cardiovascular disease (-25%), and type 2 diabetes (-14%).

• USG Cracks Down on Ultra-Processing: The HHS, FDA, and USDA launched an initiative to reduce American consumption of ultra-processed foods, which research links to cardiovascular disease, type 2 diabetes, obesity, and other health conditions. The first phase of the initiative involves creating a uniform definition to guide researchers and policymakers and considers ultra-processed foods anything from packaged snacks, to sugary drinks, cereals, and frozen dinners that undergo industrial processing.

• The Best Cardiology Hospitals: NYU Langone claimed the No. 1 spot for cardiology, heart surgery, and vascular surgery in U.S. News & World Report’s Best Hospitals rankings, ending Cleveland Clinic’s five-year reign. Mount Sinai Hospital ranked No. 2, with Cleveland Clinic dropping to No. 3. The rankings analyzed data from nearly 4,500 facilities and are weighted based on patient outcomes (45%), hospital structure (35%), expert opinion surveys (12%), patient experience (5%), and transparency initiatives (3%).

Siemens Healthineers ACUSON Origin Ultrasound System is Redefining CVUS

ACUSON Origin meets the demands of today’s cardiovascular care with AI-powered efficiency across adult and pediatric echo, vascular, structural heart, and EP. Streamlined workflows, intuitive walk-up usability, and advanced ergonomics empower clinicians to deliver confident, high-quality care—supporting a wide range of complex cases and clinical applications.

LVAD therapy receives 1A Recommendation for inotrope-dependent patients

The U.S. joint societies of the AHA/ACC/HFSA have given LVAD therapy a 1A Recommendation for heart failure patients dependent on intravenous inotropes or who cannot be weaned from temporary mechanical circulatory support. As both the strongest class of recommendation and highest level of evidence, a 1A Recommendation indicates LVAD therapy is supported by strong data and the benefits far outweigh the risks.

Redefining Percutaneous Coronary Intervention

Learn about the AGENT™ Drug-Coated Balloon from Boston Scientific and how this technology is expanding the treatment options for patients with in-stent restenosis in the U.S. Rx only. (Sponsored by Boston Scientific)

The Resource Wire

• Tempus Receives FDA 510(k) Clearance for Tempus ECG-Low EF: Tempus announces the expansion of its Tempus ECG-AI portfolio with Tempus ECG-Low EF, software intended for use to analyze 12-lead ECG recordings and detect signs associated with having a low left ventricular ejection fraction (LVEF less than or equal to 40%) in patients 40 years of age or older at risk of heart failure. It is not intended as a stand-alone diagnostic and positive results may suggest the need for further clinical evaluation. For Full Indications for Use, visit here.

• Explore Vitrea Advanced Visualization: Discover Canon Medical Healthcare IT’s suite of advanced imaging workflows designed to increase efficiency in cardiovascular imaging, and facilitate the assessment, diagnosis, and treatment of cardiovascular diseases. These cutting-edge tools support the delivery of faster, more accurate care while integrating seamlessly into clinical workflows.

• Patient Attitudes Towards Us2.ai’s AI-Echo: The medical imaging field is rapidly accepting AI, but how are patients feeling about the shift? Get the scoop on patients’ positive opinions toward Us2.ai’s software that supports task shifting from conventional echo to AI-echo.

• Personalized Plaque Analysis Now With Medicare Coverage: Heartflow’s Plaque Analysis is now reimbursable thanks to Medicare’s new coverage for AI-enabled plaque analysis of eligible patients with coronary artery disease.

• A Single Cardiac Service Line Platform: Transitioning across multiple imaging platforms is a daily reality for many cardiologists, but it doesn’t have to be. See how three leading cardiac imagers are leveraging Circle CVI’s unified multi-modal software across their diverse caseloads, without switching to other platforms.

• PIA’s Post-Processing Solution: Advanced cardiac imaging often calls for a time-consuming post-processing step, requiring costly software, hardware, and training. See how PIA provides this post-processing at lower cost, improved consistency, and greater efficiency. 

• Automate Your Echo Reporting: It’s a good feeling when your echo report is already 83% complete before you even sit down to work on it. See how Centricity Cardio Enterprise’s echo automation features make this “good feeling” an everyday occurrence in this quick GE HealthCare demo video.

The Industry Wire

1. Humana raises outlook as it navigates high medical costs.
2. Tariffs on European medicines could cost drugmakers billions.
3. Elevance names former Cencora CEO to board.
4. White House, CMS launch initiative to spur use of digital health.
5. US Senate confirms Susan Monarez as CDC director.
6. FDA’s top vaccine official, Vinay Prasad, out after 3 months.
7. Medicare Part D premiums likely to increase next year.
8. Astrana Health CEO on value-based care letdowns.
9. UVM Health lays off dozens.
10. How hospital ‘harm events’ slip through the cracks.

John Mandrola, MD introducing Edward J. Schloss, MD’s editorial in Sensible Medicine.

Cardiology Pharmaceuticals

SGLT2i Prescriptions Increase for HF, With Some Exceptions

Three years after SGLT2 inhibitors were added to the heart failure treatment guidelines, a JAMA Cardiology study reveals significant new prescriptions, with a few key patient sub-groups falling behind.

• SGLT2 inhibitors promote the excretion of sodium and glucose in the urine, which can help reduce fluid overload and improve heart function in HF patients.
• While the benefits of SGLT2is are seen across the HF spectrum, they are most established in HFrEF.

Researchers analyzed prescribing patterns of SGLT2 inhibitors for 760k HF patients in the National Cardiovascular Data Registry and found significant and rapid uptake in the last three years.

• Uptake occurred within 3 years of FDA approval for HFrEF and 1 year for HFpEF.

• SGLT2 inhibitor prescribing for all heart failure patients increased from 4.6% to 16.2% between 2019-2023.
• Breaking that down by HF subtypes, HFrEF patients saw increases from 5.1% to 28.5%, while HFmrEF/HFpEF patients increased from 4.5% to 12.8%.

However, despite the early success, researchers also uncovered some concerning disparities across patient types that were less likely to receive prescriptions such as…

• Women (aOR: 0.79).
• Older patients (aOR: 0.76).
• Patients with higher blood pressure (aOR 0.78).

Beyond the patient sub-group disparities, the study also noted that there was significant variation across 191 U.S. sites, ranging from 2% to 60% prescribing rates even after adjusting for patient and practice characteristics.

The Takeaway

Heart failure is undoubtedly one of the hardest cardiovascular conditions to treat, and while more and more pharmaceutical options are becoming available, it’s clear we have a long way to go before they’re widely accepted by physicians across the board. On the bright side, this study suggests SGLT2i’s are headed in the right direction.

Explore Vitrea Advanced Visualization

Discover Canon Medical Healthcare IT’s suite of advanced imaging workflows designed to increase efficiency in cardiovascular imaging, and facilitate the assessment, diagnosis, and treatment of cardiovascular diseases. These cutting-edge tools support the delivery of faster, more accurate care while integrating seamlessly into clinical workflow

Heartflow Roadmap Analysis For Efficient Care

As Coronary CT scan volumes increase, your entire reading team needs to deliver efficient and consistent reads. Good thing Heartflow’s Roadmap Analysis can help you maintain accuracy and increase CCTA read speeds by up to 25%, with even level 3 readers seeing real efficiency benefits.

Us2.ai’s Echo Automation Impact

Improving clinician efficiency and quality is the goal for most AI solutions, but we rarely see AI achieve both. See how the AI-ECHO RCT used Us2.ai to achieve both of those goals, while reducing sonographer fatigue in the process.

The Wire

• Heartflow Helps Physicians DECIDE: Results from Heartflow’s DECIDE Registry study suggest its AI-enabled Plaque Analysis software significantly changes patient care decisions. The study examined 20k patients across the U.S. and found that the CCTA-based Plaque Analysis software led to medical management changes in over half of patients beyond traditional CCTA scans alone. Applying the technology also resulted in an average 18.7mg/dL decrease in LDL-C and a 15% lower cardiac event risk. Unlike CCTA-alone that often misses non-calcified plaque, Heartflow’s AI quantifies all plaque types to help clinicians personalize treatment plans.

• AI for LV Dysfunction Detection: Researchers developed an AI algorithm to identify left ventricular dysfunction using routine echocardiographic measurements. The AI was tested on 81k patients and ranked them based on LV function, with the lowest dysfunction patients facing low 5-year mortality risks (2.3% for women, 5.7% for men), and the highest dysfunction patients facing far higher mortality risks (64.2% for men, and 66.3% for women). Importantly, the AI reliably identified clinically meaningful dysfunction even in patients with preserved ejection fraction and missing parameters.

• AHA’s Inflammation Detection Competition: The AHA launched a nationwide research competition to understand how inflammation contributes to cardiovascular risk. Funded partly by Novo Nordisk, the Systemic Inflammation Data Challenge offers $75k in prizes to teams using analytic software and electronic medical records to study systemic inflammation’s impact on heart disease. The challenge specifically focuses on high-sensitivity C-reactive protein testing, treatment disparities, and anti-inflammatory strategies like statins and colchicine.

• The First ECG AI Marketplace: Philips launched its ECG AI Marketplace to centralize multiple vendors’ AI algorithms for cardiac care teams. The platform aims to streamline AI workflow integration, while reducing IT costs and management complexity. Anumana is the Marketplace’s first partner, offering its FDA-cleared ECG-AI Low Ejection Fraction algorithm that detects heart failure indicators from 12-lead ECGs. With over 25 FDA-cleared ECG algorithms available on the market, Philips’ marketplace could help address growing demand for accessible AI while supporting earlier disease detection.

• Gapfill for Cardio Diagnostics: The CMS’ MolDX program issued preliminary gapfill payment rates for Cardio Diagnostics’ cardiovascular tests ($350 for Epi+Gen CHD and $684.76 for PrecisionCHD), effective January 1, 2025. Cardio Diagnostics’ tests analyze genetic and epigenetic markers from blood draws to diagnose CHD and assess three-year risk. With cardiovascular disease being the leading cause of death in the U.S., these Medicare payment rates show progress toward expanding cardiovascular testing.

• Venous Diseases are Common: The SAGE GROUP published a report quantifying chronic venous disease prevalence from 2020-2040, revealing that the disease affects 1.5 times more people than all other cardiovascular diseases combined and five times more than diabetes. Despite being highly prevalent, chronic venous disease remains underestimated, underdiagnosed, and undertreated. The most severe form, chronic venous insufficiency, increases all-cause mortality risk threefold. Over two million Americans suffered from venous ulcers in 2025, generating $55-70B in direct medical costs, with many cases underestimated due to self-treatment.

• Rocket’s 5th RMAT: Rocket Pharmaceuticals announced that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-A601, an investigational gene therapy for PKP2-arrhythmogenic cardiomyopathy. This marks Rocket’s fifth RMAT designation, providing expedited FDA review and guidance. The decision stems from Phase 1 trial results that showed encouraging safety and efficacy, with all three patients demonstrating increased PKP2 protein expression, improved heart function, reduced arrhythmias, and better quality of life.

• Philips + Epic: Philips and Epic are integrating Philips’ cardiac ambulatory monitoring and diagnostics services with Epic’s Aura specialty diagnostics suite. The integration offers the broadest cardiac care portfolio available through Aura, enabling providers to order and review ECG results directly within Epic’s EHR system. As a result, the integration eliminates manual data entry, automates patient charting, and reduces administrative burden.

• KFSHRC’s First Robo-Double-LVAD: King Faisal Specialist Hospital and Research Center achieved the world’s first robotic-assisted implantation of two artificial heart pumps for biventricular support. The surgical team used remotely controlled robotic arms to implant two Abbott HeartMate 3 ventricular assist devices in a 61-year-old patient with end-stage HF who was not a transplant candidate. The robotic approach led to lower infection risk and faster recovery. KFSHRC previously performed the world’s first fully robotic heart transplant in 2024.

• HHS Investigates Early Organ Harvesting: The HHS unveiled major organ transplant system reforms following a disturbing HRSA investigation into Kentucky Organ Donor Affiliates (KYDA). The probe found 73 patients with neurological signs incompatible with donation and 28 who may not have been deceased when organ procurement began. HHS Secretary RFK Jr. called the findings “horrifying,” citing cases where hospitals initiated organ procurement despite patients showing signs of life.

• Cardio-Microcurrent Improves HF: Berlin Heals published results in the European Journal of Heart Failure showing significant benefits of its Cardio-Microcurrent (C-MIC) device for heart failure patients. The randomized trial of 70 patients with non-ischemic dilated cardiomyopathy found that C-MIC therapy plus standard treatment improved LVEF by 6.6% versus 1.5% in controls. Additionally, 84% of C-MIC patients improved by at least one NYHA class compared to 15% of controls, with similar improvements in quality of life and walking distance.

Making the Leap to Outsource Post-Processing

Interested in how to outsource cardiac image post-processing, but not sure where to start? PIA walks you through how to assess and compare vendors, understand pricing models and payment options, and outline your requirements to identify vendors who meet your clinical needs. 

Identify and Treat Cardiovascular Disease

Complex care pathways make getting patients to the next step a challenge. See how Tempus Next, an AI enabled care pathway platform, helps providers identify and reduce under treatment in cardiovascular disease by adding an intelligent layer onto their routinely generated EHR data.

GE HealthCare Unlocks Real-Time Cardiac Insights, Anywhere, Anytime

Your workstation isn’t the only place to view cardiac images. Tune in to this online webinar on how GE HealthCare’s Zero Footprint Viewer is being used in real clinical settings to access images anywhere, anytime.

The Resource Wire

• New Horizons in Structural Heart: TAVR and TMVR rates are rising rapidly, placing more pressure on interventional planning. Tune into this Circle CVI and Radcliffe Cardiology breakout detailing how to leverage modern CT workflows to produce efficient and accurate pre-procedural plans.

• Discover Innovation in Intervention: Explore how the AGENT™ Drug-Coated Balloon from Boston Scientific is advancing U.S.-based treatment options for patients with coronary artery disease. Rx Only. (Sponsored by Boston Scientific)

• Monebo Difference in Comprehensive Cardiac Mapping: Monitoring the heart 24/7 means being in tune with the body’s natural cycles. Read about how Monebo’s approach to cardiac monitoring provides visual representations of a patient’s heart rate, cardiac muscle relaxation, and electrical excitation throughout the day.

• Merge Hemo Expands to Puerto Rico: Merge partnered with Alpha Biomedical to bring Merge Hemo to Puerto Rico, marking the software’s first expansion outside the 50 U.S. states. Read more about the work Merge is doing to expand access to its award winning solutions beyond the United States.

• 5,600 Ways to Improve Your Cardiac Ultrasound Workflow: AI-powered measurements can enhance the way you acquire and interpret cardiac ultrasound. Learn how AI-powered ultrasound can help you overcome everyday limitations in echo. Read Siemens Healthineers’ white paper on how its AI software provides 5,600+ automated measurements to help improve workflow efficiency, consistency, and clinical confidence.

• Vista AI Reduces Patient Backlog: Cardiac MRI is infamous for its complexity and backlogs, but it doesn’t need to be that way. See how Vista Cardiac delivered a 50% reduction in scan time variability, enabling shorter scheduling blocks and eliminating a one-month backlog.

The Industry Wire

1. Biggest human imaging study scans 100,000th person.
2. Republicans are split on extending Obamacare tax breaks.
3. Depressed volumes drag CHS’ second-quarter earnings.
4. UnitedHealth confirms it’s under investigation by DOJ.
5. Molina cuts 2025 earnings outlook again on ACA.
6. Epic integrates AHA’s postpartum risk assessment toolkit.
7. Aidoc raises $150M for AI foundation model.
8. Samsung’s plans to link providers to wearable devices.
9. Healthcare M&A winners and losers.
10. Charta Health picks up $22M for automated chart review.

John Mandrola, MD introducing Edward J. Schloss, MD’s editorial in Sensible Medicine.

Cardiology Pharmaceuticals

SGLT2i Prescriptions Increase for HF, With Some Exceptions

Three years after SGLT2 inhibitors were added to the heart failure treatment guidelines, a JAMA Cardiology study reveals significant new prescriptions, with a few key patient sub-groups falling behind.

• SGLT2 inhibitors promote the excretion of sodium and glucose in the urine, which can help reduce fluid overload and improve heart function in HF patients.
• While the benefits of SGLT2is are seen across the HF spectrum, they are most established in HFrEF.

Researchers analyzed prescribing patterns of SGLT2 inhibitors for 760k HF patients in the National Cardiovascular Data Registry and found significant and rapid uptake in the last three years.

• Uptake occurred within 3 years of FDA approval for HFrEF and 1 year for HFpEF.

• SGLT2 inhibitor prescribing for all heart failure patients increased from 4.6% to 16.2% between 2019-2023.
• Breaking that down by HF subtypes, HFrEF patients saw increases from 5.1% to 28.5%, while HFmrEF/HFpEF patients increased from 4.5% to 12.8%.

However, despite the early success, researchers also uncovered some concerning disparities across patient types that were less likely to receive prescriptions such as…

• Women (aOR: 0.79).
• Older patients (aOR: 0.76).
• Patients with higher blood pressure (aOR 0.78).

Beyond the patient sub-group disparities, the study also noted that there was significant variation across 191 U.S. sites, ranging from 2% to 60% prescribing rates even after adjusting for patient and practice characteristics.

The Takeaway

Heart failure is undoubtedly one of the hardest cardiovascular conditions to treat, and while more and more pharmaceutical options are becoming available, it’s clear we have a long way to go before they’re widely accepted by physicians across the board. On the bright side, this study suggests SGLT2i’s are headed in the right direction.

Explore Vitrea Advanced Visualization

Discover Canon Medical Healthcare IT’s suite of advanced imaging workflows designed to increase efficiency in cardiovascular imaging, and facilitate the assessment, diagnosis, and treatment of cardiovascular diseases. These cutting-edge tools support the delivery of faster, more accurate care while integrating seamlessly into clinical workflow

Heartflow Roadmap Analysis For Efficient Care

As Coronary CT scan volumes increase, your entire reading team needs to deliver efficient and consistent reads. Good thing Heartflow’s Roadmap Analysis can help you maintain accuracy and increase CCTA read speeds by up to 25%, with even level 3 readers seeing real efficiency benefits.

Us2.ai’s Echo Automation Impact

Improving clinician efficiency and quality is the goal for most AI solutions, but we rarely see AI achieve both. See how the AI-ECHO RCT used Us2.ai to achieve both of those goals, while reducing sonographer fatigue in the process.

The Wire

• Heartflow Helps Physicians DECIDE: Results from Heartflow’s DECIDE Registry study suggest its AI-enabled Plaque Analysis software significantly changes patient care decisions. The study examined 20k patients across the U.S. and found that the CCTA-based Plaque Analysis software led to medical management changes in over half of patients beyond traditional CCTA scans alone. Applying the technology also resulted in an average 18.7mg/dL decrease in LDL-C and a 15% lower cardiac event risk. Unlike CCTA-alone that often misses non-calcified plaque, Heartflow’s AI quantifies all plaque types to help clinicians personalize treatment plans.

• AI for LV Dysfunction Detection: Researchers developed an AI algorithm to identify left ventricular dysfunction using routine echocardiographic measurements. The AI was tested on 81k patients and ranked them based on LV function, with the lowest dysfunction patients facing low 5-year mortality risks (2.3% for women, 5.7% for men), and the highest dysfunction patients facing far higher mortality risks (64.2% for men, and 66.3% for women). Importantly, the AI reliably identified clinically meaningful dysfunction even in patients with preserved ejection fraction and missing parameters.

• AHA’s Inflammation Detection Competition: The AHA launched a nationwide research competition to understand how inflammation contributes to cardiovascular risk. Funded partly by Novo Nordisk, the Systemic Inflammation Data Challenge offers $75k in prizes to teams using analytic software and electronic medical records to study systemic inflammation’s impact on heart disease. The challenge specifically focuses on high-sensitivity C-reactive protein testing, treatment disparities, and anti-inflammatory strategies like statins and colchicine.

• The First ECG AI Marketplace: Philips launched its ECG AI Marketplace to centralize multiple vendors’ AI algorithms for cardiac care teams. The platform aims to streamline AI workflow integration, while reducing IT costs and management complexity. Anumana is the Marketplace’s first partner, offering its FDA-cleared ECG-AI Low Ejection Fraction algorithm that detects heart failure indicators from 12-lead ECGs. With over 25 FDA-cleared ECG algorithms available on the market, Philips’ marketplace could help address growing demand for accessible AI while supporting earlier disease detection.

• Gapfill for Cardio Diagnostics: The CMS’ MolDX program issued preliminary gapfill payment rates for Cardio Diagnostics’ cardiovascular tests ($350 for Epi+Gen CHD and $684.76 for PrecisionCHD), effective January 1, 2025. Cardio Diagnostics’ tests analyze genetic and epigenetic markers from blood draws to diagnose CHD and assess three-year risk. With cardiovascular disease being the leading cause of death in the U.S., these Medicare payment rates show progress toward expanding cardiovascular testing.

• Venous Diseases are Common: The SAGE GROUP published a report quantifying chronic venous disease prevalence from 2020-2040, revealing that the disease affects 1.5 times more people than all other cardiovascular diseases combined and five times more than diabetes. Despite being highly prevalent, chronic venous disease remains underestimated, underdiagnosed, and undertreated. The most severe form, chronic venous insufficiency, increases all-cause mortality risk threefold. Over two million Americans suffered from venous ulcers in 2025, generating $55-70B in direct medical costs, with many cases underestimated due to self-treatment.

• Rocket’s 5th RMAT: Rocket Pharmaceuticals announced that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-A601, an investigational gene therapy for PKP2-arrhythmogenic cardiomyopathy. This marks Rocket’s fifth RMAT designation, providing expedited FDA review and guidance. The decision stems from Phase 1 trial results that showed encouraging safety and efficacy, with all three patients demonstrating increased PKP2 protein expression, improved heart function, reduced arrhythmias, and better quality of life.

• Philips + Epic: Philips and Epic are integrating Philips’ cardiac ambulatory monitoring and diagnostics services with Epic’s Aura specialty diagnostics suite. The integration offers the broadest cardiac care portfolio available through Aura, enabling providers to order and review ECG results directly within Epic’s EHR system. As a result, the integration eliminates manual data entry, automates patient charting, and reduces administrative burden.

• KFSHRC’s First Robo-Double-LVAD: King Faisal Specialist Hospital and Research Center achieved the world’s first robotic-assisted implantation of two artificial heart pumps for biventricular support. The surgical team used remotely controlled robotic arms to implant two Abbott HeartMate 3 ventricular assist devices in a 61-year-old patient with end-stage HF who was not a transplant candidate. The robotic approach led to lower infection risk and faster recovery. KFSHRC previously performed the world’s first fully robotic heart transplant in 2024.

• HHS Investigates Early Organ Harvesting: The HHS unveiled major organ transplant system reforms following a disturbing HRSA investigation into Kentucky Organ Donor Affiliates (KYDA). The probe found 73 patients with neurological signs incompatible with donation and 28 who may not have been deceased when organ procurement began. HHS Secretary RFK Jr. called the findings “horrifying,” citing cases where hospitals initiated organ procurement despite patients showing signs of life.

• Cardio-Microcurrent Improves HF: Berlin Heals published results in the European Journal of Heart Failure showing significant benefits of its Cardio-Microcurrent (C-MIC) device for heart failure patients. The randomized trial of 70 patients with non-ischemic dilated cardiomyopathy found that C-MIC therapy plus standard treatment improved LVEF by 6.6% versus 1.5% in controls. Additionally, 84% of C-MIC patients improved by at least one NYHA class compared to 15% of controls, with similar improvements in quality of life and walking distance.

Making the Leap to Outsource Post-Processing

Interested in how to outsource cardiac image post-processing, but not sure where to start? PIA walks you through how to assess and compare vendors, understand pricing models and payment options, and outline your requirements to identify vendors who meet your clinical needs. 

Identify and Treat Cardiovascular Disease

Complex care pathways make getting patients to the next step a challenge. See how Tempus Next, an AI enabled care pathway platform, helps providers identify and reduce under treatment in cardiovascular disease by adding an intelligent layer onto their routinely generated EHR data.

GE HealthCare Unlocks Real-Time Cardiac Insights, Anywhere, Anytime

Your workstation isn’t the only place to view cardiac images. Tune in to this online webinar on how GE HealthCare’s Zero Footprint Viewer is being used in real clinical settings to access images anywhere, anytime.

The Resource Wire

• New Horizons in Structural Heart: TAVR and TMVR rates are rising rapidly, placing more pressure on interventional planning. Tune into this Circle CVI and Radcliffe Cardiology breakout detailing how to leverage modern CT workflows to produce efficient and accurate pre-procedural plans.

• LVAD Therapy Receives 1A Recommendation for Inotrope-Dependent Patients: The U.S. joint societies of the AHA/ACC/HFSA have given LVAD therapy a 1A Recommendation for heart failure patients dependent on intravenous inotropes or who cannot be weaned from temporary mechanical circulatory support. As both the strongest class of recommendation and highest level of evidence, a 1A Recommendation indicates LVAD therapy is supported by strong data and the benefits far outweigh the risks.

• Discover Innovation in Intervention: Explore how the AGENT™ Drug-Coated Balloon from Boston Scientific is advancing U.S.-based treatment options for patients with coronary artery disease. Rx Only. (Sponsored by Boston Scientific)

• Monebo Difference in Comprehensive Cardiac Mapping: Monitoring the heart 24/7 means being in tune with the body’s natural cycles. Read about how Monebo’s approach to cardiac monitoring provides visual representations of a patient’s heart rate, cardiac muscle relaxation, and electrical excitation throughout the day.

• Merge Hemo Expands to Puerto Rico: Merge partnered with Alpha Biomedical to bring Merge Hemo to Puerto Rico, marking the software’s first expansion outside the 50 U.S. states. Read more about the work Merge is doing to expand access to its award winning solutions beyond the United States.

• 5,600 Ways to Improve Your Cardiac Ultrasound Workflow: AI-powered measurements can enhance the way you acquire and interpret cardiac ultrasound. Learn how AI-powered ultrasound can help you overcome everyday limitations in echo. Read Siemens Healthineers’ white paper on how its AI software provides 5,600+ automated measurements to help improve workflow efficiency, consistency, and clinical confidence.

• Vista AI Reduces Patient Backlog: Cardiac MRI is infamous for its complexity and backlogs, but it doesn’t need to be that way. See how Vista Cardiac delivered a 50% reduction in scan time variability, enabling shorter scheduling blocks and eliminating a one-month backlog.

The Industry Wire

1. Biggest human imaging study scans 100,000th person.
2. Republicans are split on extending Obamacare tax breaks.
3. Depressed volumes drag CHS’ second-quarter earnings.
4. UnitedHealth confirms it’s under investigation by DOJ.
5. Molina cuts 2025 earnings outlook again on ACA.
6. Epic integrates AHA’s postpartum risk assessment toolkit.
7. Aidoc raises $150M for AI foundation model.
8. Samsung’s plans to link providers to wearable devices.
9. Healthcare M&A winners and losers.
10. Charta Health picks up $22M for automated chart review.