Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Clears Apple Watch Heart Rate Accessory

PharmaLive news release; 2017 Nov 30

AliveCor, the leader in FDA-cleared personal electrocardiogram (EKG) technology, has announced FDA clearance of KardiaBand in the US, allowing Apple Watch users to discreetly capture their EKG anytime, anywhere in order to quickly detect normal sinus heart rhythms and atrial fibrillation (AFib), the most common heart arrhythmia and a leading cause of stroke. The first FDA-cleared medical device accessory for Apple Watch, KardiaBand can record an EKG in 30 seconds with just a touch of its integrated sensor. AliveCor is also introducing 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 SmartRhythm detects that heart rate and activity are out of sync, the device notifies users to capture an EKG with KardiaBand, or with KardiaMobile, AliveCor’s popular, portable EKG reader. AliveCor is a privately-held company headquartered in Mountain View, CA.


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

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