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CVD’s Global Burden, FDA Cracks Down, and Philips + Optum September 29, 2025
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Together with
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“We’ve developed strong tools to fight hypertension, yet the burden persists. Why? Because behind the numbers lies a hidden driver – psychological stress. Unless we address this root cause, CVD will remain an unending burden.”
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Hardik D. Desai, Review Editor at Frontiers in Cardiovascular Medicine.
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Coronary artery disease and the calcification that follows it represents one of the most challenging conditions that interventional cardiologists treat today. Thankfully, with the advent of intravascular lithotripsy, providers are getting a new more effective tool to treat these patients. Read this Cardiac Wire exclusive to find out how Abbott is developing its own IVL system and where it’s headed.
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The latest Global Burden of Disease study revealed that cardiovascular disease is a bigger part of the global health battle than previously thought, underscoring the impact of CVD on population-level health despite medical advances.
- Cardiovascular disease remains the leading cause of death and disability worldwide, mostly through ischemic heart disease (8.9M deaths) and stroke (6.8M deaths).
- Nearly 80% of cardiovascular disability-adjusted life years (DALYs) stem from modifiable risk factors, yet risk factor control hasn’t improved.
Presented at the UN General Assembly 2025, the Global Burden of Disease study looked at cardiovascular disease patterns across regions and sociodemographic indices from 1990-2023, revealing some very concerning trends…
- High blood pressure emerged as the leading global risk factor, followed by poor diet, high LDL cholesterol, and air pollution.
- Countries with low-to-middle development faced the largest CVD burden, with the South Pacific showing the highest DALY rates (10,344 per 100,000).
- Men experienced 42.9% increases in cardiovascular DALYs since 1990 compared to 28.6% increases in women, indicating gender-specific risk factors.
- Metabolic risk factors showed alarming growth, with DALYs from high BMI increasing 114% and high fasting glucose climbing 76% over the study period.
Despite the effective treatments available, researchers emphasized that “cardiovascular disease continues to increase for almost all of the world,” with obesity and diabetes now actively driving disease expansion.
- Regional risk factor patterns varied, with hypertension dominating in sub-Saharan Africa while tobacco and alcohol use drove burden in Eastern and Central Europe.
- Lead exposure from industrial sources, ceramics, electronics, and food also represents an “underappreciated risk factor” contributing significantly to ASCVD.
Now that cardiovascular disease is pretty treatable, one could argue that the persistent global burden highlights massive healthcare access and delivery failures rather than therapeutic limitations.
- Researchers noted that effective treatment requires proper healthcare access and functioning EMS systems, disproportionately affecting lower-resource settings.
The Takeaway
Although cardiovascular disease treatments have never been more effective, the global burden continues rising due to a lack of risk factor control and persistent healthcare access barriers. As several other CVD reports have already shown this year, protecting our hearts is a population-level issue, not an individual one.
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Changes in Heart Failure Management
Heart failure is a complex condition with high heart failure hospitalization and cardiovascular mortality rates, especially among patients with HFpEF and HFmrEF, for whom treatment options have been limited. Read how Bayer’s Dr. Alanna Morris-Simon discusses the changing treatment landscape and strategies for improving patient outcomes.
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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.
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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.
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- Abbott’s Coming IVL System: Severe calcification due to CAD is one of the most complex challenges interventional cardiologists face in today’s treatment landscape. While some more traditional methods of treating CAD include cutting balloons and atherectomy, intravascular lithotripsy is quickly emerging as a promising treatment option. In our latest Cardiac Wire exclusive, Abbott goes in depth on their investigational IVL system and its potential to change the CAD treatment paradigm.
- FDA Cracks Down on Drug Ads: The FDA just fired off over 100 warning letters to drugmakers and care providers for misleading advertisements. Most of those letters (nearly 60) ended up in the inboxes of companies like Hims and Hers that offer compounded versions of GLP-1s, which aren’t FDA approved despite what their ads are leading consumers to believe. Recent research suggests that 37% of websites marketing compounded GLP-1s either explicitly state or imply that the drugs are approved.
- Caristo’s CaRi-Heart Added to CPT Codebook: Caristo Diagnostics highlighted that its CaRi-Heart AI technology falls under the AMA’s CPT codes 0992T and 0993T from the freshly released 2026 CPT Codebook. The codes cover AI-powered analysis of perivascular fat and cardiovascular risk assessment from coronary CT scans. CaRi-Heart falls under the codes since it uses AI to detect coronary inflammation and can potentially predict heart attacks up to a decade in advance through its proprietary FAI-Score.
- U.S. Probes Medical Device Imports: The tariff wars could get real for manufacturers of imported medical devices, including medical equipment. The U.S. Department of Commerce last week said it was investigating medical imports under a federal law that allows the government to restrict or impose tariffs on imports that “threaten to impair” national security. Imports in question include personal protective equipment, medical consumables, and medical devices.
- One-Minute Whole-Heart MRI for Kids: It can be a challenge to get kids to stay still in an MRI bore long enough to acquire quality cardiac images. Researchers developed a one-minute whole-heart protocol that’s optimal for assessing congenital heart disease. The protocol uses the iron supplement ferumoxytol off-label as a contrast agent in combination with a 3D ultrashort echo time sequence, and in 38 patients produced acceptable image quality compared to the standard sequence.
- Ultromics’ EchoGo Efficacy: Ultromics recently announced study findings that showed their EchoGo Amyloidosis AI can improve early cardiac amyloidosis detection. By analyzing 4.8k patient cases from 17 hospitals, the AI increased correct referral rates from ~65% to 76-80% in low-prevalence scenarios while reducing unnecessary referrals by 18% in high-prevalence settings. With up to 66% of cardiac amyloidosis cases going undiagnosed, the FDA-cleared system analyzes echocardiograms at the pixel-level to identify subtle patterns, potentially enabling earlier treatment when therapies are most effective.
- Why TAVR Patients Get Pacemakers: A study of over 2k TAVR patients found that 24.3% of those receiving permanent pacemakers received them for preventive reasons, mainly for persistent left bundle branch block. While the study revealed that 30-day clinical outcomes were similar between preventative and non-preventative groups, preventative pacemaker patients had significantly lower ventricular pacing rates (2% vs 73%) and higher rates of minimal pacing (<1%).
- Wrong Heart, Right Place: A 64-year-old Virginia man had a massive heart attack while driving home from the gym, causing him to stop breathing and crash his car. Miraculously, he crashed near a cardiologist’s office, allowing the doctor to perform CPR for over eight minutes, saving the man’s life from sudden cardiac death. The patient’s “widow maker” artery was 90% blocked, despite being an athlete who ran marathons. The patient later admitted he had ignored subtle warning signs and now urges others to monitor their heart health.
- WVU Medicine’s Growing Heart: A new report reveals that WVU Medicine’s Heart and Vascular Institute has grown dramatically in under a decade. Once part of a small university health system, WVU Medicine’s HVI grew from a small 25-provider program generating $225M annually, to a major healthcare destination with over 200 providers bringing in $2B (with 450k patient visits in 2024). The teams at the institute also performed world-first robotic cardiac procedures, including TAVR explant and combined robotic AVR with coronary bypass.
- Philips + Optum: Philips announced a national partnership with Optum Healthcare, making Philips’ Mobile Cardiac Telemetry and Extended Holter available to 3.4M Optum members across 22 U.S. states. The duo believes benefits will include reduced specialist referral delays, enhanced diagnostic insights, and improved patient compliance with monitoring devices that potentially support proactive cardiac care management.
- Axon Raises Feasibility Funds: Axon Therapies closed a $32M Series A funding round as part of an effort to bolster its research pipeline. Now in the clinical-stage, the medical device company will use the funds for two heart failure feasibility studies of its novel splanchnic ablation therapy. Called Satera, the ablation system is an implant-free, catheter-based procedure that targets sympathetic nervous system overactivity to treat heart failure.
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Timely Evaluation and Referral for LVAD Therapy is Critical for Advanced Heart Failure Patients
Without an LVAD or transplant, advanced heart failure patients would not be expected to survive beyond 1 year.2,3,* But with nearly 60% survival at 5 years, HeartMate 3 LVAD is a proven long-term, life-extending therapy for advanced heart failure patients.1
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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.
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Why Competitors Benchmark Against Monebo’s ECG Algorithm
In the world of cardiac monitoring, it’s a big deal when your competitors use your technology as their benchmark for success. Learn why Monebo Technologies’ ECG analysis algorithm has been the “predicate device” of at least 13 other companies FDA 510(k) clearance regulatory filings and what this means for providers and their patients.
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- Relieving The Burden of Post-Processing: With the advent of advanced imaging technologies like CCTA come added burdens to technologists and diagnostic imaging centers. See how PIA can relieve the burden of post-processing, saving you time while helping your bottom line.
- 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.
- 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.
- Us2.ai’s AI HF Now Possible with Handheld Echo: The latest research shows Us2.ai’s software can take handheld echocardiography beyond its standard applications. Read this EHJ study about how swiftly and accurately Us2.ai’s HF detection software detects LVEF, closely matching expert human analysis of standard cart based echocardiograms.
- The Largest Registry on Plaque Analysis in CAD: What if 50% of your CCTA patients could benefit from an adjustment to their treatment plan? Read more about Heartflow’s DECIDE registry that demonstrates how Heartflow Plaque Analysis using its Plaque Staging software empowers physicians with clinical insights that lead to real-world impact.
- Streamlining Cath Lab Hemodynamic Workflows: Is your hemodynamic solution keeping your cath lab efficient? Merge Hemo is a cath lab hemodynamic monitoring solution, providing a Best in KLAS user experience, while enhancing clinical workflows, automating data collection, and streamlining inventory management.
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