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AI-ECG’s Strong Start | VARIPULSE’s Stroke Scare
January 9, 2025
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Together with
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“I’m excited to see how AI can help us analyze complex medical data and improve patient outcomes in cardiology, but let’s prioritize patient safety and transparency in its integration.”
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Dr. Robert Thompson, MD
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The buzz around artificial intelligence’s impact on cardiology keeps growing louder, and that’s proving to be particularly true in the AI-ECG segment, with 2025 already off to a strong start from ECG startups and researchers alike.
- AI and ECG pair well due to the strong pattern recognition that machine learning algorithms can achieve.
- This AI-ECG pairing is bringing the modality into a wider range of diseases and allowing integration with new device form factors.
One pertinent example is AccurKardia’s recent FDA breakthrough designation for its ECG-based, AI-powered AK+ Guard hyperkalemia detection software.
- AK+ Guard uses Lead I ECG data to alert patients and clinicians of moderate to severe episodes of excess blood potassium (hyperkalemia) that can lead to sudden cardiac arrest.
- Accurkardia designed AK+ Guard for consumer and clinical wearables to support remote hyperkalemia monitoring for patients with renal disease, CKD, and other risk factors.
- For reference, 37M people in the U.S. suffer from CKD, and hyperkalemia is associated with a 16.6% higher mortality rate in those patients.
Tackling another CV complication, researchers developed an AI-ECG risk estimator for hypertension (AIRE-HTN) that could become a useful tool for predicting future CV events.
- AIRE-HTN was trained on ~190k patients at Beth Israel Deaconess and validated on 65k patients from UK Biobank.
- Ultimately, the study found that patient AIRE scores accurately predicted CV death (HR: 2.24), HF risk (HR: 2.60), MI (HR: 3.13), ischemic stroke (HR: 1.23), and CKD (HR: 1.89) compared to traditional risk factors.
The commercial side of the AI-ECG arena is similarly heating up, including a new partnership between AliveCor and ECG AI developer Anumana.
- The partnership will focus on AliveCor’s Kardia ECG devices and Anumana’s ECG-AI algorithms, and apparently includes both AI development and integration.
- Their first target will be Anumana’s ECG-AI algorithm, which detects low ejection fraction using 12-lead ECG data, and recently landed CMS reimbursement.
The Takeaway
Though there’s no shortage of AI skeptics in healthcare, it’s becoming clear that AI is bringing ECG into new disease areas and form factors. For a modality as established as ECG, that’s a big deal, and it could have a major impact on both disease detection and patient access.
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- BSCI Bolts Into LVI Arena: Boston Scientific took a major step into the intravascular lithotripsy arena, acquiring Bolt Medical for $600M and up to $300M in milestones. The Bolt IVL system creates acoustic pressure waves inside of a balloon catheter to fracture calcified lesions, and is the focus of several pivotal coronary and peripheral artery trials. Although J&J/Shockwave clearly leads the IVL segment, Boston Scientific has been developing its IVL strategy for some time, including establishing Bolt Medical in 2019 as a 25% owner.
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- Stryker Strikes at VTE: Stryker acquired Inari Medical for ~$4.9B to expand into the rapidly growing peripheral vascular and VTE segment and help treat the 900k+ patients who suffer from the disease in the United States. Inari’s product portfolio will be integrated into Stryker’s Neurovascular business and includes mechanical thrombectomy solutions for peripheral vascular diseases such as deep vein thrombosis and pulmonary embolism. Following the acquisition, Stryker aims to use its global infrastructure to accelerate the development of new VTE-centered technologies.
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