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Medical Devices / Submissions and Approvals

AliveCor Scores FDA Clearance for First Apple Watch Medical Device Accessory

Dec. 5, 2017

The FDA cleared the first medical device accessory, manufactured by California-based developer of personal electrocardiogram (EKG) technology AliveCor for the Apple Watch.

KardiaBand can record an EKG in 30 seconds and detect normal sinus heart rhythms as well as atrial fibrillation, the most common heart arrhythmia.

The product requires a subscription from AliveCor for use with the Apple Watch. The Kardia app features the company’s SmartRhythm, which can continuously monitor the correlation between users’ heart and physical activity, using artificial intelligence, to notify them when an EKG should be captured.

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