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Sudden Cardiac Death, Apple Watch ECG, and Atrium’s Milestone
May 4, 2026
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Together with
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“In wellness whoever has the best story wins, right? That’s all you need to say is ‘I got this great story, buy my watch.’ But you really need data to back that up.”
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Kenneth Civello, MD, MPH, on the wearables industry at HRS 2026.
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Hello everyone! It’s Vik from Cardiac Wire and I just got done moving from NYC to Colorado, right in time for my birthday today! So, I made sure this issue is a good one (as always).
On a more professional note, my colleague and Managing Editor of The Imaging Wire, Brian Casey, is preparing a special webinar in partnership with Agfa HealthCare on what clinicians need to accelerate their imaging workflows in radiology and cardiology. You can register here!
Thank you for being a reader!
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It’s not often that a pair of studies completely challenges our assumptions in cardiology, but new data presented at HRS 2026 suggests myocardial infarction might not be the main cause of sudden cardiac death (SCD).
- The WHO defines SCD as an unexpected death within an hour of symptoms or within 24 hours of last being seen alive and in which a cardiac cause is assumed without autopsy.
- Since the 1970s, the hypothesis has been that ~80% of SCD cases are due to MI.
- This thinking stemmed from early SCD autopsies, but those cases were limited, and referral bias likely played a role.
Despite how far cardiology has come in treating the heart, annual SCD incidence remains high. This prompted researchers to continuously watch presumed SCD cases in San Francisco County for 12 years. What they found completely overturned our current understanding of SCD.
- Among 943 cases studied, only 41% of those with confirmed SCD showed MI as cause of death.
- Of those MI deaths (n=237), 90% showed evidence of CAD, with 95 identified as acute MI and 119 as healed MI.
Researchers then used the autopsy data to conduct a second study and found that…
- Out of the 943 cases examined, 58% had SCD due to arrhythmic causes, meaning that an implanted or external defibrillator might have been able to save them.
So what to do with this data?
- For starters, it helps us understand that sudden cardiac death isn’t so sudden after all, and what we call SCD is the manifestation of undetected arrhythmia or heart disease.
- It could also encourage strengthening screening programs and expanding heart disease prevention beyond just avoiding MI.
The Takeaway
While seemingly small in scope, these two studies represent a watershed moment in our understanding of sudden cardiac death. It’s clear now that it isn’t a random event spurred on by a freak heart attack, but rather the manifestation of undetected heart disease.
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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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The Growing AI-CCTA Adoption
CCTA and AI-enabled coronary plaque analysis are now reimbursed standards of care. That means your program could risk leaving clinical impact and revenue on the table if it doesn’t adapt. Register today for an exclusive Circle Cardiovascular Imaging webinar on May 5th to learn how to update your workflows and streamline physician effort.
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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.
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- Apple Watch Doubles Arrhythmia Detection: The PAWS study, presented at HRS revealed that the Apple Watch captured twice as many arrhythmia events as traditional patch monitors in children aged 6-28. Among 107 children, 79% of the Apple Watch’s ECG tracings rated high quality while accurately identifying AFib and supraventricular tachycardia in 73% and 75% of cases, respectively. Researchers clarified that the watch data should still be interpreted by professionals to maintain diagnostic specificity. Check out Cardiac Wire’s interview with Kenneth Civello, MD, for more on this topic.
- GLP-1s and AFib: TRANSFORM-AF stole the show at last year’s HRS, suggesting there might be a link between GLP-1s and a lower AFib risk. This year’s HRS saw four studies saying the same thing. Across the studies, one trend was consistent, patients who took GLP-1s faced a lower incident AF risk. However, it’s worth noting that these results are all just associations. There still isn’t a clear mechanism beyond the CV benefits of weight loss to explain this risk reduction.
- PlaqueTec’s $5M Fundraise: UK-based PlaqueTec secured $5M from existing investors to expand BioCarta, its proprietary “data lake” of proteomic and clinical insights. PlaqueTec uses a specialized intracoronary liquid biopsy catheter to sample biomarkers directly at the site of plaque formation within the heart’s arteries. The company is still conducting the BIOPATTERN trial to identify unique inflammatory drivers of cardiovascular disease, which it believes will enable better patient stratification and the identification of new therapeutic targets for pharmaceutical partners.
- Atrium’s BMS Milestone: Atrium Therapeutics earned a $15M development milestone from Bristol Myers Squibb following the delivery of an unnamed lead development candidate for a cardiovascular indication. This marks the first licensed compound under a global collaboration focused on RNA-based therapies that target the heart directly using antibody-oligonucleotide conjugates. Under the deal, Atrium is eligible for over $2B in total potential milestone payments plus tiered royalties, with BMS assuming all future costs for clinical development, regulatory filings, and commercialization.
- VASCADE MVP XL in Large-Bore Closure: Haemonetics have outdone themselves after a recent study found that their VASCADE MVP XL outperformed their standard VASCADE MVP system in large-bore venous access procedures. The larger catheter achieved a 0% bleeding complication rate in all 573 patients. These results supported the FDA’s decision to grant the device expanded labeling, approving the XL system for procedural sheaths up to 14F inner diameter (17F outer diameter). This expansion makes it the only extravascular closure system compatible with high-growth technologies like the FARAPULSE PFA and WATCHMAN LAAO.
- Coramitug’s FDA Fast Track: The FDA granted Fast Track Designation to coramitug, an investigational amyloid depleter antibody for treating ATTR-CM. Developed by Novo Nordisk, the monoclonal antibody targets misfolded transthyretin to trigger its active clearance—a mechanism distinct from current therapies that merely slow disease progression. Coramitug is currently being evaluated in the global Phase 3 CLEOPATTRA trial involving 1,280 participants, with the designation intended to expedite the review of this potentially life-saving treatment for a population with significant unmet medical needs.
- Reflow Medical’s Next-Gen Cora Microcatheters: Reflow Medical launched the Cora Flex and Cora Force microcatheters in the United States. By utilizing proprietary Cora Tech, these devices allow the physician to rotate the catheter without the issue of guidewire lock-up. The Flex model is used to navigate tortuous vessels (twisty and squiggly), while the metal-tipped Force model slides through stubborn, calcified lesions (crunchy and blocked). Reflow believes these enhancements in torque and pushability will streamline complex coronary interventions by making the catheter-based device more maneuverable.
- Rocket Pharma Monetizes PRV: Rocket Pharmaceuticals sold its Priority Review Voucher—awarded following the March 2026 FDA approval of KRESLADI—for $180M. This non-dilutive funding extends Rocket’s cash runway into Q2 2028, supporting its leading cardiovascular gene therapy pipeline. Key programs receiving the investment include RP-A501 for Danon disease, RP-A601 for PKP2-ACM, and RP-A701 for BAG3-DCM. The transaction highlights the PRV program’s continued value following its February 2026 reauthorization by Congress.
- AVIM’s Second FDA Breakthrough Designation: Orchestra BioMed earned a second Breakthrough Device Designation for its AVIM Therapy, targeting 7.7 million U.S. adults with uncontrolled hypertension. Currently in the BACKBEAT Global Pivotal Trial with Medtronic, AVIM uses specialized cardiac pacing to manage blood pressure in pacemaker-indicated and high-risk patients. This designation will expedite the FDA’s review process while unlocking favorable reimbursement pathways like New Technology Add-on Payment and Transitional Pass-Through for the treatment.
- Implicity’s AI Slashes False Positives: Two recent data readouts from EHRA and HRS showed that Implicity’s next-generation ILR ECG Analyzer reclassified 61.6% of false-positive alerts while maintaining 98.3% sensitivity. By acting as a manufacturer-agnostic, cloud-based “dual AI” layer, the system filters out non-actionable noise that proprietary device algorithms often miss. As a result, the technology significantly reduces clinician alert fatigue and streamlines remote monitoring workflows without compromising patient safety.
- J&J Acquires HOTWIRE: Further expanding its cardiac intervention portfolio, Johnson & Johnson agreed to acquire Atraverse Medical, the maker of the HOTWIRE RF guidewire and HOTWIRE Transseptal Access System. Atraverse previously received FDA clearance for the transseptal device in 2025 and RF guidewire in 2024 while raising roughly $32M in funding around the same time. While we don’t know how much J&J paid, HOTWIRE’s automatic energy shutoff and multi-sheath compatibility will fit nicely within J&J’s cardiac ablation portfolio.
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How Vista AI Helps Solve the Technologist Shortage
Fewer than 2% of MRI scanners are routinely used for cardiac imaging—mainly due to a shortage of trained technologists amid rising demand. Vista AI addresses this challenge by automating CMR scanning, empowering technologists of all experience levels to deliver high-quality cardiac exams consistently and efficiently.
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What Every Cardiologist Needs to Watch for in Heart Failure
Patients with preserved (HFpEF) or mildly reduced ejection fraction (HFmrEF) face a high risk of hospitalization for heart failure and cardiovascular death, even with guideline-directed medical treatment. Hear from Bayer’s Dr. Alanna Morris-Simon as she shares common heart failure signs to look out for.
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How to Improve Cardiology Workflows and Get More Patient Time
Complex processes and reporting requirements can mean cardiologists spend more time with clinical systems than they do with their patients. See how Merge Hemo and Merge Cardio work together to help you streamline and scale your clinical and data management workflows, so you can have more time in front of your patients.
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- The Power of AI in Cardiovascular Imaging: Cardiac labs are under more pressure than ever to deliver more with greater speed and precision. Hear from ACUSON Origin customer, Tony Gallagher about how Siemens Healthineers’ cardiovascular ultrasound system is improving exam efficiency and showing positive impact on ROI.
- How Us2.ai Improves CA Screening: Cardiac amyloidosis may not be as rare as previously thought, with early and accurate detection becoming increasingly critical for treatment. Read about how the AI-SCREEN-CA study implemented Us2.ai’s automated CA reporting and AI-based pattern recognition analysis, leading to better disease screening at scale.
- A Cardiovascular Ultrasound Platform You Can Trust: Being able to provide premium diagnostic information for your pediatric patients every day, all day, is vital. Find out why cardiac imagers trust Fujifilm’s Lisendo 880, and how its premium imaging quality, efficiency tools, and reliability you can trust, have helped change workflows for clinicians and technologists alike.
- 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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