AliveCor gets FDA nod for 12-lead, AI-powered ECG machine

By Mario Aguilar June 25, 2024

AliveCor has spent years battling with Apple over the market for consumer heart monitoring technology. Now it’s hoping to make its imprint on professional health care with its new device, which recently received clearance from the Food and Drug Administration.

The 12-lead electrocardiogram device, called the Kardia 12L ECG System, is a hand-held version of the standard ECG device usually found in hospitals and used to diagnose heart conditions. The company also received FDA clearance for KAI 12L, the software that can analyze ECGs to detect up to 35 conditions including arrhythmias, like atrial fibrillation, and other issues, like heart attacks. The FDA clearance documents make clear that the new device and software are intended for professionals and are not a replacement for a standard 12-lead ECG.

Because the device is compact and easy to use, the company hopes Kardia 12L will be used in settings that don’t already have ECG machines on hand, and in particular, that it will accelerate decision-making around heart attacks. Speaking from a conference in Sweden, the company’s chief medical officer Dave Albert observed the prevalence of automatic external defibrillators in the country.

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Health Tech Correspondent

Mario Aguilar covers technology in health care, including artificial intelligence, virtual reality, wearable devices, telehealth, and digital therapeutics. His stories explore how tech is changing the practice of health care and the business and policy challenges to realizing tech's promise. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter.

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