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No JenaValve for Edwards, More Acquisitions, and the Food Pyramid
January 15, 2026
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Together with
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“One person’s personal bias doesn’t mean 24h shifts aren’t useful. Just to counter this, I’m extremely grateful for my 24h shifts in medical school and residency. It absolutely helped me prepare, honed my ability to triage while exhausted, and made me a better doctor.”
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Anthony DiGiorgio, DO, MHA
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Following a six-month antitrust fight, Edwards Lifesciences has been forced to walk away from its $945M attempt to buy fledgling valve developer JenaValve after a U.S. district court ruled in favor of the FTC’s decision to block the move.
- Edwards first announced the JenaValve deal in July 2024, aimed at bringing the company’s Trilogy TAVR system into its robust structural heart portfolio.
- The deal would’ve allowed Edwards to lock down the TAVR-for-aortic-regurgitation market, since the company already has a duopoly with Medtronic in TAVR for AS.
The FTC’s big issue didn’t just start Edwards acquiring JenaValve, rather it was the short timespan in which the structural heart giant went after another valve developer.
- Edwards almost simultaneously acquired JC Medical in a $116M upfront deal for its aortic regurgitation TAVR program in August 2024.
- To the FTC, this meant Edwards was trying to buy the category’s two most advanced TAVR for AR options.
That’s why the FTC sued in August 2025 under the pretense that the merger could reduce competition for AR treatments, diminish product quality, and increase prices, an argument which ultimately held up in court.
So what’s next for the top TAVR company in the U.S.? Edwards says it’s still all-in on treating aortic regurgitation with TAVR using its own SOJOURN transcatheter AR valve while enrolling patients in the JOURNEY pivotal trial that is testing the J-valve it acquired from JC Medical.
- In the meantime, the big medtech players like Boston Scientific and Johnson & Johnson are likely to bid over who gets JenaValve next.
The Takeaway
This court ruling is a reminder that you can’t buy up all of the best tech in a specific sector, at least not when it comes to structural heart medtech. It also keeps the door open for competition in the U.S. on the TAVR front, something that Edwards has only had to deal with from Medtronic.
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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
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Changes in Heart Failure Management
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- Vista AI Nabs $29.5M in Series B: Automated MRI software company Vista AI closed a Series B funding round that raised $29.5M. Vista will use the funds to expand remote scanning abilities for cardiac MRI while building out new clinical applications, in brain, prostate, and spine imaging. The company’s ultimate goal is to offer a broad platform for automated MRI scanning that can assist MRI technologists and reduce scan variability and complexity.
- Abbott + AtaCor = Extravascular ICD: Abbott will collaborate with AtaCor Medical to advance a new extravascular implantable cardioverter defibrillator system that delivers therapeutic shocks from outside the heart and blood vessels. AtaCor’s parasternal Atala lead will be paired with Abbott’s investigational ICD system, potentially reducing vascular injury, lead fractures, and infections. AtaCor plans to initiate the ALARION EV pivotal IDE trial in 2026 to evaluate the system.
- Gaps in Smoking Cessation Care: A survey in JACC Advances of nearly 500 cardiologists caring for hospitalized patients found that only ~12% work at hospitals with a dedicated tobacco cessation program. The survey showed that lack of support staff (66%), funding (63%), and administrative resources (42%) are the main barriers, while medications like varenicline and bupropion remain underprescribed due to safety concerns. Notably, 41% of respondents said they would lead an inpatient tobacco treatment team if given resources.
- Bayer Acquires Amyloidosis Imaging Agents: Pharmaceutical giant Bayer is adding molecular imaging to its contrast media business by acquiring radiotracers under development for cardiac amyloidosis imaging by pharmaceutical company Attralus. Attralus specializes in diagnostic and therapeutic agents for cardiac amyloidosis, and Bayer is acquiring its AT-01 PET tracer (phase III) and AT-05 SPECT tracer (phase I). AT-01 is a pan-amyloid PET agent with both orphan and breakthrough designations, while AT-05 is a technetium-based SPECT agent.
- Light Physical Activity & CKM Syndrome: A new analysis of more than 7k adults found that 3-5 hours of daily light-intensity physical activity led to significantly lower all-cause mortality in patients with cardio-kidney-metabolic syndrome. Researchers followed patients for 14.4 years on average and found that each 1-hour increase in light exercise lowered mortality risk between 14% and 20%, with the benefit highest in patients with CKM stage 4. The findings suggest everyday activities may offer meaningful survival benefits, particularly for patients unable to perform higher-intensity exercise.
- Elevated Lp(a) Predicts Long-Term CV Risk: Further confirming the relationship between Lp(a) and CV risk, a new analysis of the Women’s Health Study found that higher lipoprotein(a) levels are associated with an increase in cardiovascular events. The study examined CV risk across Lp(a) levels and found that major CV risk was 16% higher at 30–60 mg/dL and nearly 55% higher at ≥120 mg/dL compared to women with levels below 10 mg/dL. Very high Lp(a) levels were also strongly linked to cardiovascular death and ischemic stroke.
- Radiation Protection During PCI: A recent study in JSCAI suggests that using Rampart’s enhanced radiation protection system during PCI for STEMI doesn’t significantly increase door-to-balloon times compared to standard lead aprons. The study recorded and compared D2B times among 174 STEMI patients undergoing PCI and found that median times were ~31 minutes in both groups, meeting noninferiority criteria. Researchers say this means radiation protection can be integrated into time-critical STEMI workflows without compromising care quality.
- CVAUSA Partners With Ascertain for AI: Cardiovascular Associates of America (CVAUSA) partnered with Ascertain to deploy agentic AI across its network of 460+ cardiologists and 100+ clinics to automate prior authorizations, documentation, and payor communications. The collaboration could potentially reduce administrative burden across CVAUSA’s growing network of partnered physicians, which might in turn improve patient outcomes. The partnership comes just a few days after CVAUSA’s most recent acquisition to expand its network.
- UltraSight Expands FDA Clearance: UltraSight received FDA clearance to expand its Echo Stewardship Platform compatibility to manufacturer agnostic handheld, laptop, and cart-based ultrasound systems. The move will enable health systems to scale AI-guided cardiac ultrasound using existing equipment. Ultrasight’s platform provides real-time acquisition guidance and quality scoring to help support clinician-performed scans with cardiologist oversight and without hardware replacement.
- The New Food Pyramid: The 2025–2030 Dietary Guidelines for Americans recently debuted as a streamlined 10-page document urging people to “eat real food,” emphasizing whole foods while cutting highly processed products and limiting alcohol. The AHA and ACC welcomed the focus on minimally processed diets, fruits/vegetables, and sugar reduction, but flagged departures from prevention guidance like the prioritization of animal protein, endorsement of full-fat dairy, and unclear messaging on fats and sodium.
- PulseAI Closes Seed Round: PulseAI announced the completion of a Seed funding round (undisclosed amount) to support the expanded deployment of its AI-enabled ECG decision-support platform and advance toward FDA 510(k) clearance. The company aims to use the technology to reduce diagnostic variability and delays in ECG interpretation, putting it in a similar category to companies like PMCardio, Anumana, and AccurKardia.
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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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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.
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The Hidden Costs of Delaying Cardiac MRI Adoption
Despite being the gold standard for functional cardiac imaging, many hospitals remain slow to adopt it. From missed revenue to lost patients, the impact goes far beyond the scan. Read about the real clinical and financial risks of falling behind.
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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.
- 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.
- 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.
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