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Winrevair’s HF Win, GEHC Buys Intelerad, and Beta-Blockers Post-MI
November 24, 2025
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Together with
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“Fewer than 25% of docs remain independent. Curious how many would reconsider that arrangement with some systemic changes (like a repeal of the POH ban) where the leverage starts to shift back a bit to the physician side? Could be a renaissance in the works if we’re brave enough to pursue it.”
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Sanat Dixit, MD, FACS
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Cardiology Pharmaceuticals
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Winrevair (sotatercept-csrk) might become Merck’s next blockbuster after positive Phase 2 results from the CADENCE study showed it led to significant improvements in pulmonary blood flow in patients with precapillary pulmonary hypertension due to HFpEF.
- Heart failure with preserved ejection fraction (HFpEF) makes up more than 50% of the 6.7M U.S. HF cases, which is both a strain on the healthcare system and a pharmaceutical opportunity.
- Initially developed for PAH, Merck acquired Winrevair through its $11.5B Acceleron Pharma acquisition in 2021.
- The FDA has approved several HFpEF treatments but Winrevair is a new mechanism that targets activin protein signaling to regulate cell growth and division.
Focused on exploring Winrevair’s HF impact, the Phase 2 CADENCE study enrolled 164 adults with PAH caused by HFpEF, comparing two Winrevair doses against placebo over approximately six months and found that…
- Winrevair provided “significant and clinically meaningful” improvement to pulmonary blood flow at six months compared to placebo, meeting the study’s main goal.
- The trial also specifically targeted HFpEF patients with secondary pulmonary hypertension, a subset experiencing particularly severe symptoms and complications.
With FDA approval secured for PAH, Merck is aggressively pursuing HFpEF expansion as part of its strategic response to impending Keytruda patent expiration threatening half its pharmaceutical revenue.
- Winrevair generated $976M in sales over the first nine months of 2025 based solely on its PAH indication which suggests strong commercial traction and adoption.
- A big part of this rapid adoption stems from just how effective Winrevair is at treating PAH, with trials and real-world practice singing its praises alike.
The study is part of a larger HFpEF pharma trend, as Winrevair was not initially intended for HF, just like Bayer’s Kerendia (finerenone) which was originally a kidney drug.
- Both cases are indicative of just how devastating but lucrative HF is, since both the FDA and developers are quick to test drugs that don’t necessarily address the underlying mechanisms of HFpEF.
- That said, reducing symptoms and improving the patient’s overall quality of life following HF diagnosis are still solid reasons for earning an HF indication.
The Takeaway
Though only topline, Winrevair’s Phase 2 results bode well for Merck’s HF plans. We’ll have to wait and see if the full analysis and Phase 3 results back an FDA approval, but if they do, physicians will have yet another HF treatment in their toolkit, something that just ten years ago seemed like a distant possibility.
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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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Cracking the Code of ECG Analysis with Monebo’s AI Genetic Algorithm
How do you teach a computer to recognize the complex patterns in an ECG signal? Discover how Monebo found the answer by blending human expertise and a little evolutionary magic in this article that breaks down the advantages of genetic algorithms in ECG analysis.
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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.
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- Beta-Blockers Don’t Do Much Post-MI: A meta-analysis of nearly 18k heart attack patients with LVEF ≥50% found that beta-blocker therapy provided no significant clinical benefit. After 3.6 years, the primary composite endpoint (all-cause mortality, myocardial infarction, heart failure) occurred in 8.1% of beta-blocker patients versus 8.3% of controls. Researchers suggest patients with preserved LVEF experience smaller infarctions with less scarring, making them less vulnerable to arrhythmias where beta-blockers would help.
- GE Brings Intelerad Into the Fold: GE HealthCare will acquire Intelerad for $2.3B in cash to advance its cloud-enabled enterprise imaging across care settings. Intelerad’s cloud-first medical imaging software and strong outpatient presence complements GE HealthCare’s hospital-based imaging solutions, creating a comprehensive AI-enabled ecosystem spanning academic centers to ambulatory networks. The acquisition brings AI workflow orchestration, cloud PACS, and image sharing in a SaaS model, accelerating GE HealthCare’s goal to triple cloud-enabled products by 2028.
- Chronic Pain and High BP: Chronic pain could increase your risk of hypertension. A U.K. Biobank study of over 200k patients found that those with chronic widespread pain faced the highest risk of hypertension (75% increase), while chronic abdominal, headache, and neck pain also significantly elevated risk. Depression played a role in about 11% of the pain-hypertension association, and inflammation played a small role (0.4%). Experts recommend monitoring blood pressure in chronic pain patients and treating them with standard antihypertensive medications.
- Riverain’s Opportunistic CAC AI: A recent Nature study demonstrated that Riverain Technologies’ AI algorithm can calculate coronary artery calcium scores from non-contrast CT scans with near-radiologist accuracy. In a study of 491 patients across five U.S. hospitals, the AI showed high agreement with radiologists (kappa 0.959) and performed consistently across demographics and scanner types. Riverain’s technology was FDA-cleared in December 2024 and continues to enable efficient CAC scoring from routine CT exams without separate cardiac scans.
- SCAI Takes on Non-Competes: SCAI released a response to the FTC stating that it supports banning physician noncompete contracts, arguing they unfairly restrict cardiologists and harm patient care. The statement notes that 85% of SCAI’s members are now hospital-employed, up from 15-20% in 2010, while 45% of all physicians face noncompete clauses. These contracts force doctors to relocate far away for new jobs and disrupt patient-physician relationships. SCAI rightfully contends that these noncompetes don’t benefit physicians or patients, instead serving corporate interests in an increasingly consolidated hospital market.
- Smartwatch AFib Showdown: A new meta-analysis of 26 studies took a look at how today’s leading smartwatches stack up when it comes to detecting atrial fibrillation. Six of the seven brands included in the analysis had “excellent diagnostic accuracy” – sorry Fitbit – and could precisely identify patients both with and without AFib. The Apple Watch came in fourth for AFib performance (94% sensitivity, 97% specificity), while the Amazfit ranked first with an unbelievable 99% sensitivity and 99% specificity (a stat that industry insiders are already doubting).
- Apple Fined in Masimo Case: In other Apple Watch news, a federal jury ordered the Cupertino tech giant to fork over $634M for violating Masimo’s blood-oxygen reading patents. The court found that the Apple Watch’s workout mode and heart rate notification feature both infringed on Masimo’s IP, which concludes another branch of the six-year legal battle. Some Apple Watches received an import ban in 2023 that prompted Apple to release new versions of the tech, but the two companies are still duking it out with U.S. Customs over the legality of the updated watches.
- TeraRecon’s AI Investment: Advanced visualization software developer TeraRecon released a new version of its 3D software while revealing a new investment in the AI market. TeraRecon AV is a cloud-based application with new features that automate previously manual tasks, including for cardiac interventional procedures. Meanwhile, TeraRecon DETECT is a new platform that helps clinicians identify clinical applications for which AI reimbursement is available, like arterial plaque analysis.
- VahatiCor’s CMD Series B: VahatiCor closed $23M in Series B financing to advance its A-Flux Reducer System for coronary microvascular dysfunction (CMD), which affects up to 4M Americans, predominantly women. The device uses a self-expanding nitinol frame placed in the coronary sinus to optimize blood flow and reduce chest pain in patients without major artery blockages.
- Vasa Fast-Tracks VS-041: Vasa Therapeutics received FDA fast track designation for its VS-041 oral therapy for fibroinflammation in HFpEF. The small molecule inhibitor has already demonstrated safety and tolerability in healthy adults and is currently undergoing a proof-of-mechanism study in HFpEF patients (expected to complete by July 2026). Fast track designation enables more frequent FDA meetings and potential accelerated approval, underscoring the unmet medical need of targeting HFpEF’s underlying mechanisms.
- A New Way to Dress “Smart”: Hexoskin earned FDA 510(k) clearance for its Medical System smart shirt that provides continuous ECG and respiratory monitoring. Hexoskin uses AI algorithms to identify digital biomarkers beyond traditional cardiopulmonary monitoring. The company also developed an AI model for cough detection that maintains patient privacy by not recording conversations, even in noisy environments, making it possible to use for remote care and decentralized trials.
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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.
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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.
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Circle CVI’s CAD-RADS Rundown
Ever wondered how CAD-RADS enhances the communication of coronary artery disease findings from imaging studies? Check out this guide from Circle Cardiovascular Imaging about the evolution of CAD-RADS and how to incorporate it into your practice.
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- 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.
- 9 Merge Cardio Features to Change Your Cardiology Workflows: Having the right tools is essential for efficient cardiology imaging workflows and delivering exceptional patient care. Read this article on how Merge Cardio can make the biggest difference to your imaging workflows, care team user experiences, and patient care delivery.
- 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 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.
- 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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