FDA Clears AliveCor’s Credit-Card-Sized Personal ECG

February 7, 2022

AliveCor has received the FDA’s 510(k) clearance for its KardiaMobile card, a personal electrocardiogram device the size of a standard credit card.

The device delivers a medical-grade, single-lead ECG in 30 seconds, according to the Mountain View, Calif.-based company.

The card, which can detect six of the most common arrhythmias, pairs with a smartphone giving users access to cardiologist analyses of the ECGs and monthly heart health reports.

The device’s algorithm uses AliveCor’s artificial intelligence-based Kardia technology, which has been evaluated in more than 170 peer-reviewed studies, the company said.

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