Dr. Spencer Nadolsky, MD reacting to Novo Nordisk’s new partnership with Hims & Hers.

The Cardiac Wire Show captured key insights into the latest electrophysiology breakthroughs and products at this year’s HRS 2025 in interviews with… 

• Mount Sinai Hospital’s Joshua Lampert, MD on how calibrating diagnostic and screening AIs is critical to their actual clinical performance.

• GE HealthCare’s Travis Luck on the full suite of GE Centricity Cardio Enterprise and its supporting products.

• Vektor Medical’s Rob Krummen on the company’s mission and upcoming clinical studies.

Cardiology

Cardiac Wire’s Top Six of HRS 2025

Heart Rhythm Society and sunny San Diego brought together the biggest HRS in years, with everything from custom presentation theaters to exciting afterparties. We hope everyone who attended HRS 2025 had as much fun as we did, and we hope all of you enjoy these top-six takeaways from electrophysiology’s biggest weekend of the year.

HRS Keeps Growing – The HRS annual meeting surpassed its pre-COVID numbers, as HRS 2025 crossed the 10k attendee mark (up from 9,588 last year), and the conference’s packed exhibit hall reflected the new growth.

Goodbye RFA, Hello PFA – Pulsed field ablation stepped on stage last year, but it’s now the star in the spotlight, with every major biotech firm touting a PFA device, and even Kardium, an independent contender aiming to best them all in design and outcomes.

EP’s Data Boom – As EP’s scientific studies grow, the thirst for data inspired several device data management companies to show up this year, as they offered up new ways to process procedural and ECG data for researchers and clinicians alike. 

PFA and Pacemaker Results – HRS’ late breaker presentations were dominated by PFA safety and efficacy studies with a smattering of pacemaker studies targeting the left bundle branch, speaking to the innovations in more efficient ablation and pacing.

AI Momentum Remains – AI continued its strong presence at HRS, but this year it was all about integration and supporting modalities from ECG to periprocedural Echo. Almost all remote patients monitoring vendors and device data managers mentioned AI in their products in some way.

RPM Maturation – Speaking of RPM, the industry showed a lot of maturity this year, with established incumbents growing the market while innovative start-ups try to disrupt the space with new device form factors and data applications.

AI-Echo for Cardiac Amyloidosis

Despite advancements in cardiac imaging, cardiac amyloidosis remains significantly underrecognized and underdiagnosed. Discover how Us2.ai’s deep learning diagnostic algorithm uses echocardiography and apical 4-chamber DICOM images to detect CA.

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.

Merge and Duly Health Streamline Cardiology Reporting

Over the last 10 years, Dr. Sujith Kalathiveetil of Duly Health and Care has seen a significant evolution in cardiovascular imaging and experienced a similar evolution with Merge’s cardiology solutions. See how Merge Cardio has helped make cardiology reporting more consistent, accurate, and easier to obtain for Dr. Kalathiveetil and his colleagues.

The Wire

• iRhythm Zio Stands Out: Latest data from the AVALON study indicates that iRhythm’s Zio Long-Term Continuous Monitoring could lead to higher diagnostic yield and better outcomes compared to other LTCM products. AVALON examined 428k patients and found that those who used the Zio LTCM service had the highest adjusted odds of diagnosing their arrhythmia within 90 days (2X higher than Holter monitors, 1.69X higher than AEM, and 1.56X higher than other LTCMs). Zio LTCM also had the lowest probability of re-testing and cardiovascular events.

• Abbott AVEIR CSP’s Early Results: Presented as an HRS late-breaker, Abbott’s first-in-human study for its AVEIR Conduction System Pacing leadless pacemaker suggests that the device could effectively perform left bundle branch area pacing (LBBAP). Among 14 patients enrolled to receive the AVEIR CSP, 10 successfully completed the procedure and LBBAP capture was observed in 5 out of those 10 patients. Freedom from serious adverse events within 1 month of implantation was 85.7%, suggesting the AVEIR CSP device achieved clinically acceptable intraprocedural electrical performance and safety.

• Message Received for mRNA Therapy in ARVC: Examining mouse models of arrhythmogenic right ventricular cardiomyopathy (ARVC) caused by Dsc2 gene loss, researchers discovered that a single dose of Dsc2 mRNA restored heart size and function for 2–3 months. The intervention also worked in mice with pressure overload–induced RV dysfunction. Dsc2 variants account for 1.6% of ARVC cases, and current therapies with beta-blockers or antiarrhythmics don’t improve survival benefits.

• OCT Beats Angio for Stent Placement: Results from the CALIPSO trial suggest intravascular optical coherence tomography is more accurate than conventional angiography for guiding stent placement in patients with calcified coronary lesions. The JAMA Cardiology study examined 134 patients, finding that stents placed under OCT guidance had a 23% larger minimal stent area (6.5 vs. 5 mm²), with smaller areas boosting the risk of stent failure. OCT can be especially valuable in preparing calcified lesions before stent placement, such as with intravascular lithotripsy.

• Transverse’s Series B2: Transverse Medical completed its Series B2 financing round, securing over $10 million in new capital for the development of its POINT-GUARD Cerebral Embolic Protection (CEP) device for use during TAVR. The fresh funds will support POINT-GUARD’s active Feasibility Clinical Study in Australia. Transverse will also use some of the funding to expand its engineering, regulatory, quality, and operating teams as it prepares for pivotal trials and FDA IDE submission.

• Another DCB on The Way? The FDA granted Orchestra BioMed an Investigational Device Exemption (IDE) to test an updated design of its Virtue Sirolimus AngioInfusion Balloon (SAB) in the Virtue Trial. The IDE gives Orchestra BioMed FDA regulatory clearance to begin a U.S. pivotal clinical trial comparing its Virtue SAB to the Boston Scientific AGENT paclitaxel-coated balloon which is currently the only drug-coated balloon approved for a coronary indication.

• HRS/ACC Ablation Discharge Guidelines: New HRS/ACC guidelines suggest many patients can avoid an overnight stay after intracardiac catheter ablation procedures. The new document outlines discharge eligibility criteria, including no decompensated HF or unstable medical comorbidities that need acute management post-procedure. Proximity of the patient’s home to the hospital and his/her social support are also among the factors physicians should consider before discharging ablation patients. 

• HeartBeam Earns VALID Results: Results from the VALID-ECG study suggest HeartBeam’s portable synthesized 12-lead ECG device could be as good as the ones taken in hospitals. Researchers in VALID-ECG evaluated the average difference in ECG intervals and amplitudes between HeartBeam’s device and standard 12-lead ECGs, finding that the two had a 93.4% overall diagnostic agreement. As a result, HeartBeam believes its device could support diagnosis of arrhythmias similarly to standard 12-leads.

• Abbott MPU Recall: The FDA announced that Abbott is recalling the mobile power units (MPUs) associated with some of its HeartMate left ventricular assist devices (LVADs). This Class I recall covers certain MPUs used with both the HeartMate 3 LVAD and HeartMate II LVAD and warns that using the devices “may cause serious injury or death.” The recall stems from reports that the MPUs are suddenly turning on, turning off, or restarting and advises providers to return any unused devices directly to Abbott.

• FDA Approves Medtronic OmniaSecure: Medtronic received FDA approval for its OmniaSecure defibrillation lead for right ventricle placement. The OmniaSecure lead is catheter-delivered and connects to an implantable defibrillator to help treat various arrhythmias. Medtronic claims the OmniaSecure’s 1.6mm size makes it the world’s smallest defibrillation lumenless lead while reducing the risk of complications. Data from HRS 2025 also found that implanting the OmniaSecure in the Left Bundle Branch was associated with high defibrillation success in 100% of patients.

• X-Ray AI Predicts Heart Disease: Chest X-ray isn’t usually thought of as a cardiac imaging modality, but AI could change that. As part of a JACC: Advances study, researchers from South Korea tested an AI algorithm that detects heart disease by analyzing cardiovascular borders on chest X-rays. Testing 44.6k patients, the algorithm showed potential in classifying and stratifying a patient’s risk of a cardiac abnormality, and calculated cardiothoracic ratios that predicted five-year risk of death or MI (HR=3.73).

The All in One Cardiac Imaging Solution

Ready for an all-in-one solution that supports all of your MR and CT needs? See how Circle Cardiovascular Imaging’s cvi42 can streamline your core reading and reporting workflows within a single, customizable platform.

The CardioMEMS HF System is Now Covered by Medicare Advantage

Find reimbursement resources and more information about the expanded coverage for your heart failure patients if coverage criteria is met.

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 Resource Wire

• 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.

• Innovating AFib Care: The first manifestation of AFib is often stroke, but many hospitals aren’t set up to coordinate these patients’ post-stroke care. See how UCSD is leveraging Viz.ai’s Viz Connect solution to simplify neuro and EP collaboration in this HRX 2024 interview.

• 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.

• 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.

• 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)

• Experience the future of learning: Medtronic Academy 2.0 is here! Unlock your ultimate destination for structural heart medical education with the newly redesigned Medtronic Academy 2.0. Gain access to expert-led courses, webinars, and a wealth of resources to stay ahead in cardiovascular care. Visit now!

• Making Cardiovascular Data Work for You: Today, cloud-native analytics can automate data acquisition and synthesize complex data. Discover what Optum’s technology can do to facilitate future advancements in cardiovascular data and analytics.

• Cut Waste with GE HealthCare’s Inventory Management: Want to make your hospital’s inventory practices more efficient? Tune in to this webinar on how GE HealthCare’s data-driven insights can optimize inventory management and reduce cardiac procedure times by 30-45 minutes.

• The 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.

The Industry Wire

1. FDA misses review deadline for genetic drug candidate.
2. Supreme Court sides with HHS on hospital payments.
3. Tenet to continue M&A for ambulatory surgery centers. 
4. C-suite compensation grew 20% in 2024. 
5. FDA ruling ends era of compounded GLP-1 weight-loss drugs.
6. Humana to shore up Medicare Advantage business. 
7. Penn. bill would legalize OTC ivermectin sales. 
8. GOP senator calls for reversal of federal research cuts.
9. FDA debates whether to approve seasonal COVID shots.
10. RFK Jr.: Don’t flush unused medications.