AliveCor’s KardiaBand is the FDA’s First Medically Approved Accessory for the Apple Watch

November 2017 - The U.S. Food and Drug Administration (FDA) cleared the first medical accessory for the Apple Watch, AliveCor’s KardiaBand which uses the Watch’s heart rate technology and sensors to provide EKGs in as little as thirty seconds. The Watch pairs with the KardiaBand via Bluetooth and can detect abnormal heart rhythm and, for the first time, atrial fibrillation. This new feature is a game changer for patient self-monitoring says AliveCor CEO Vic Gundotra, who in an interview with TechChrunch said, “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, let’s get an EKG reading.’ It’s not possible to diagnose atrial fibrillation without FDA clearance. That is a big, big play.”

 

The device, which is worn as a band that the Apple Watch fits into, does not have any more sophisticated sensors than the Watch, rather, Apple would require FDA clearance to be able to diagnose atrial fibrillation. Instead, the device relies on AliveCor’s SmartRhythm technology, which uses deep neural networks and a user’s heart rate data to determine their unique heart health profile. This data is then presented on the Watch, which displays the abnormal heart rate detected, your normal heart range, and where the EKG falls into that range. Speaking to KardiaBand’s status as the Watch’s first FDA-approved accessory he wrote, “This is a medical device. This is not a toy that says your heart might be irregular. This is an FDA-cleared device. It’s one of the hardest things I’ve ever done in my life.”