STAT+: AliveCor gets FDA nod for portable 12-lead, AI-powered ECG device

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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