Clinical Edge

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FDA Approves EKG Device for Apple Watch

AliveCor news release; 2017 Nov 30

The US Food and Drug Administration has approved KardiaBand, the first medical device accessory for the Apple Watch that captures an electrocardiogram (EKG) in order to quickly detect normal sinus heart rhythms and atrial fibrillation (AF). The device can record an EKG in 30 seconds with a touch of its integrated sensor and results from the Kardia App are displayed on the face of the Apple Watch.

Simultaneously being introduced is SmartRhythm, a new feature within the Kardia app for Apple Watch. SmartRhythm uses artificial intelligence in concert with inputs from Apple Watch’s heart rate and activity sensors to continuously evaluate the correlation between heart activity and physical activity. When it detects that heart rate and activity rate are out of sync, the device notified users to capture an EKG with KardiaBand, or with KardiaMoble, the company’s portable EKG reader.


FDA clears first medical device accessary for Apple Watch. [news release]. Mountain View, CA: AliveCor, Inc. November 30, 2017. Accessed December 1, 2017.