FDA approves first EKG reader for Apple Watch

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Date: Friday, December 1st, 2017, 03:42
Category: Apple Watch, Health, iOS, News, Software, watchOS, Wearables

The FDA has just cleared the first medical device accessory for the Apple Watch. AliveCor’s KardiaBand electrocardiogram (EKG) reader functions as a sensor that pairs with an app and can detect abnormal heart rhythm and atrial fibrillation (AFib). The user touches the sensor, which snaps into a slot on the watch’s band, to get an EKG reading in 30 seconds. The recording can then be sent to a doctor.

The KardiaBand can then predict and analyze the user’s heart rate based on data from both sick and healthy users.

AliveCor’s CEO Vic Gundotra, formerly of Google, offered the following comments:


“Apple might be able to say ‘oh your heart rate is high’ …but what does that mean? Does that mean you should go to the hospital? And if you go to the hospital what are they going to do? Any doctor will say ‘ok come in, lets get an EKG reading. It’s not possible to diagnose atrial fibrillation without FDA clearance. That is a big, big play.”

Apple has an initiative called the Apple Heart Study and plans to use heart rate data in building further research.

AliveCor also announced the SmartRhythm feature in its Kardia app, which uses AI to analyze data from the watch’s heart rate and activity sensors. The app will evaluate the correlation between heart rate and activity, and if these appear abnormal, will alert the user to capture another EKG reading. A speech recognition function also allows patients to describe their symptoms aloud to the watch. The app will then generate analysis based on the data, which can be emailed to the user’s doctor.

KardiaBand is available now for $199, and requires a subscription to AliveCor’s premium service, which costs $99 a year.

The Kardia app is available for free and require iOS 10.0 or later to install and run.

Via The Verge, TechCrunch and Bloomberg

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