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AI for HF Frailty, FDA Approvals Galore, and Jupiter’s Vertex
By Viktor Zarev
October 22, 2026
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Together with
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“I personally believe that there is probably an inverse relationship between the number of procedures done and the understanding of the underlying pathophysiology for which the procedure is performed.”
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Jeffrey J. Goldberger MD, MBA in his editorial viewpoint on how procedural electrophysiology has become.
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For those of you who missed our webinar in partnership with Canon Medical HIT on the best practices for starting a cardiac CT program, you can now watch it on YouTube.
For those of you interested in cardiac industry news, it was a big week for medtech, so check out the Wire section.
For those of you interested in research, today’s top story should satisfy that craving. If not, we’re 10 days away from back-to-back weekends of late-breaker studies, so bear with me.
And for those of you who read Cardiac Wire – a big thank you.
Viktor (Vik) Zarev, Senior Editor
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Functional decline and frailty in older heart failure patients can rapidly decrease their lifespan and it’s hard to quantify by how much – but a new study in the Journal of Cardiac Failure suggests machine learning could change that.
- One of the biggest issues with HF’s disease trajectory is the decline in activities of daily living (ADL) following a patient’s first hospitalization.
- When daily activity decreases, patients quickly lose independence, which actually increases rehospitalization and mortality risk.
- That means it’s critical to predict a patient’s timeline toward this first hospitalization and take steps to prevent it for as long as possible.
That’s where this JCF study comes in, with Japanese researchers developing and training an ML model on 6k older hospitalized HF patients from the J-Proof HF Registry to predict where patients would fall into one of three one-year functional categories: maintenance, decline, or death.
- Specifically, researchers tested two different versions of the model (one with 77 variables and one with only 10) against the Kihon Checklist frailty screening tool.
- Both the 77 and 10 variable versions achieved an AUC of 0.75 versus 0.66–0.69 for the KCL tools.
Diving deeper into the model’s prediction data then revealed that physical function mattered more than cardiac function for a patient’s frailty trajectory.
- For example, variables like gait speed, preadmission frailty, and discharge ADL scores outweighed ejection fraction as predictors.
- In fact, it’s possible that a patient’s extracardiac reserve (the blood supply to organs outside the heart) largely dictated whether a patient remained independent.
Importantly, researchers also identified a subgroup of patients (n=1.7k) that had an 89% survival probability according to traditional screening tools but faced a 57% rate of functional decline.
- A mortality-focused model would flag them as low-risk but these are the people who survive heart failure just to lose their independence.
The Takeaway
With heart failure, time is of the essence, and the sooner a patient’s decline is identified, the more we can improve disease trajectory. This study tells us that machine learning can aid in predicting that decline while questioning the way we currently measure it.
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Integrating AI for Enhanced Echo
Sometimes it pays dividends to be an early adopter. Find out how the Christ Hospital’s early evaluation of Merge Cardio 12.5 allowed for remote echocardiography measurements, enhanced reporting accuracy, and a seamless user experience, bringing even greater efficiencies and clinical confidence.
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Canon’s 30 Years of Caring
For over 30 years, Canon has helped advance pediatric interventional cardiology through innovation and a commitment to better care. Learn more about how and why modern pediatric cardiac angiography came to be from one of its founding members, Dr. John P. Cheatham.
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Pulmonary Hypertension Detection With a Single Echo Clip
Pulmonary hypertension is often diagnosed late, when irreversible vascular remodelling has already occurred. That’s changing, however, with Us2.ai’s spatiotemporal transformer technology that can process apical four-chamber echo and accurately detects pulmonary hypertension far beyond the single-view echocardiographic benchmark.
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- Elucid’s FFR-CT Earns FDA Clearance: The AI-based fractional flow reserve CT (FFR-CT) race just got its third competitor with the FDA clearance of Elucid’s FFR-IQ solution. Elucid claims its software differences make FFR-IQ the “most accurate” tool for assessing coronary artery narrowing from CCTA scans. Another potential differentiator for Elucid is FFR-IQ’s use of its BioIntegrated FFR-CT technology, which combines analysis of coronary anatomy with plaque composition to estimate coronary physiology and deliver more personalized patient assessments.
- Philips to Acquire Cardiac Informatics Firm: Philips is acquiring MediReport, a French developer of cardiovascular information systems and structured reporting software. The company’s MediReport 360 application enables healthcare providers to capture cardiovascular clinical information once and use it across different locations in an enterprise. This acquisition could allow Philips to eventually pair MediReport’s tech with its own cardiovascular informatics solutions like Cardiovascular Workspace and Ultrasound Workspace. The companies have been partnering in Europe since January 2026.
- J&J Launches a New Shockwave: Johnson & Johnson MedTech launched the Shockwave C2 Aero Fly Coronary IVL Catheter in the U.S., ahead of TCT 2026, to stay ahead of the IVL development curve. The next generation device delivers pulses twice as fast as prior versions, minimizes balloon inflation time, and cuts the pause between pulsing cycles in half, from 10 seconds to five. J&J says the device updates are meant to support faster cath lab workflows for complex, high-volume cases.
- Medtronic’s New Pacemakers Get CE Mark: Speaking of next-gen devices, Medtronic secured CE mark approval for its Vitalis portfolio of pacemakers built for conduction system pacing (CSP). The CE marking spans the ReSyncra CSP, Restoria CSP, Refina CSP, Effectra, and Confirma devices. All of the newly marked devices feature RadiaSure technology to help patients tolerate cancer-treatment radiation and Allometric Pacing to personalize their pacing rates by height and ejection fraction.
- Edwards’ Pascal Goes Tricuspid: In more big regulatory news for Edwards, the structural heart giant received FDA approval for its Pascal Precision system to treat symptomatic severe tricuspid regurgitation. The indication is for symptomatic patients who don’t respond to optimal medical therapy and are deemed appropriate by a heart team for the device. Originally approved for mitral repair in 2022, Pascal is now cleared for both mitral and tricuspid transcatheter edge-to-edge repair.
- Masimo’s Pulse Ox Can Spot AFib: Just a few days after a favorable court decision for its Apple lawsuit, Masimo notched FDA clearance for its smartSET pulse oximetry platform to now identify signs of AFib. Once the arrhythmia is detected, smartSET sends alerts to the Radius Vital Signs Monitor. This combined feature continuously evaluates pulse waveform data, flagging clinicians when follow-up may be needed. Masimo believes this approach will help catch silent arrhythmias that develop between routine rounds on general care floors.
- Abbott’s Amulet Recall Over a Labeling: Abbott is recalling its Amplatzer Amulet Left Atrial Appendage Occluder due to an updated instructions-for-use document warning against implanting the device too close to the pulmonary artery, which raises the risk of perforation. No devices need returning and clinicians are instead directed to read the new implantation guidance. The updated instructions now specify that implant distances of 1.5 mm or less from the pulmonary artery carry significant risk. The FDA tagged it a Class II recall covering eight model numbers.
- A Pivotal Trial for Pulmonary Embolectomy: New results from Jupiter Endovascular’s SPIRARE II trial suggest the Vertex Pulmonary Embolectomy System is safe and effective. Across 123 patients who had their PE removed by the device, the 48-hour major adverse event rate was just 2.4%, with their RV/LV diameter ratio dropping from 1.44 to 1.05, meaning that both metrics met their prespecified endpoints. The Vertex system uses Jupiter’s Transforming Fixation technology to balance the catheter’s flexibility for navigation with control stability.
- FDA Clears a New Haemonetics Closure Device: Haemonetics received FDA approval for its PerQseal Elite vascular closure system for large-bore arterial procedures, expanding its structural heart and endovascular portfolio following its January 2026 acquisition of Vivasure Medical. The sutureless system uses a fully bioabsorbable patch to seal arteriotomies up to 26F from within the vessel, enabling near-instantaneous hemostasis while letting physicians maintain guidewire access and reposition until release. The approval stems from the ELITE study that showed 0% major complications and sub-one-minute hemostasis.
- An Oral Stabilizer for AL Amyloidosis: Protego Biopharma received FDA IND clearance for its drug PROT-001 that stabilizes light chain amyloidosis. The IND now allows Protego to launch its SHIELD-ALpivotal Phase 2/3 study for evaluating PROT-001’s efficacy in newly diagnosed light chain amyloidosis patients. PROT-001 works by directly neutralizing the toxicity of amyloidogenic light chains which complements current plasma cell-directed therapies that reduce their production. The company aims to show whether this approach yields deeper, faster organ responses and fewer cardiovascular complications.
- Smartphone BP Screening Initiative: Australia’s Helfie AI and UK-based Health Innovation South West partnered to explore how smartphone-based hypertension screening can support earlier cardiovascular risk assessment. The collaboration will test and evaluate Helfie’s technology like remote photoplethysmography (skin scanning) and conversational health questions in real-world settings, with the intent of integrating the tech into existing healthcare pathways. The duo hopes any findings will add to the evidence base for digital-first approaches to cardiovascular disease prevention.
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How Automated MRI Software Transformed Radiology Regional
Radiology Regional recently integrated automated MRI scanning software into their imaging practice imaging. Hear from their team how automating CMR scans streamlined their practice and enhanced patient care.
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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.
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State-of-the-Art Cardiac Monitoring at Scale
Cleared for 13 different heart rhythm interpretations, AccurKardia’s AccurECG 2.0 shortens the time from an arrhythmia incident to clinical intervention. Watch here to find out how AccurKardia and Specialized Medical are teaming up to bring the AccurECG 2.0 technology to clinicians across the U.S.
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- Beyond Heart Rate – What ECG Intervals Can Reveal: The ECG waveform contains more information than heart rate alone. For device makers and cardiac software developers, interval measurement is an important part of translating raw signals into usable data. Explore Monebo’s Kinetic Intervals technology and its role in ECG analysis.
- Bring AI Into Your Cardiac Care Workflow: Viz.ai’s Cardio Suite helps teams flag suspected disease, access cardiac imaging, and coordinate care.
- HFSA Late-Breaker Findings: New research presented as a Late Breaker at HFSA demonstrated that patients receiving CCM® Therapy experienced significant long-term improvements in heart failure hospitalization rates and other key measures of cardiac health, including NT-proBNP, functional status, quality of life, and diuretic use… Read More.
- VASCADE MVP® XL Vascular Closure System: Sometimes EP procedures call for a venous vascular closure system that is simply bigger. Haemonetics’ VASCADE MVP XL closure system comes with 58% more collagen and a 9% larger disc compared to the VASCADE MVP system as well as an expanded indication for utilizing 10-14F inner diameter sheaths.
- How to Operationalize and Scale a New CV Service Line: Advances in AI, imaging, and coronary CT are creating new opportunities for cardiovascular care. Explore this Frost & Sullivan Executive Brief for the key things to consider when establishing a coronary plaque service line—from choosing your delivery model to integrating AI cardiovascular imaging workflows and capturing reimbursement value.
- Change Healthcare and Optum Unite: Change Healthcare and Optum merged five years ago to advance a more modern, information and technology-enabled health care platform. Read more about how, and why, Change Healthcare became Optum.
- Fujifilm’s Ultrasound for every Cardiovascular Ultrasound Environment: From academia to clinical diagnostics, versatility in cardiac ultrasound is essential. Discover why clinicians are choosing Fujifilm’s LISENDO 880 for exceptional image quality, comprehensive strain analysis, stress imaging, and innovative Virtual Contrast technology — all while delivering outstanding value.
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