FDA Clears First Medical Device Accessory for Apple Watch®


Medical wearable device technology has just crossed a threshold: AliveCor (Mountain View, CA) announced today that its KardiaBand has been cleared by FDA, making it the first Apple watch accessory to be classified as a medical device in the United States. It costs $200 and is on sale from Amazon and AliveCor's site, and you don't need a recommendation for a doctor to use it - it's meant for consumers, and anyone who might want to keep a closer watch on their heart or those concerned with heart issues like sinus heart rhythms or atrial fibrillation.

Vic Gundotra, CEO of AliveCor told TechCrunch, "Apple might be able to say "oh your heart rate is high" ...but what does that mean?" Machine learning algorithms, dubbed SmartRhythm, then sift through data gathered by Apple Watch's sensors to establish a normal band of heart rate activity. Those participating in the Apple study will get automatic monitoring of their heart rhythm 24 hours a day, if they are found to have a problem, once their patch arrives.

FDA Clears First Medical Device Accessory for Apple Watch®

EKG readings typically are conducted in doctors' offices and hospitals after a life-threatening event. The new SmartRhythm feature taps into AI and when combined with the Watch's heart rate data and activity sensors will evaluate the correlation between heart activity and physical activity. Atrial fibrillation is is the most common heart arrhythmia, and a leading cause of stroke.

Note, there have been a couple studies conducted using just the Apple Watch's built-in heart rate monitor to detect an abnormal heart rhythm. The regulatory nod covers AliveCor's KardiaBand, a device that clips onto Apple's smartwatch and performs EKG readings.

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AliveCor has launched (and received FDA clearance for) a new ECG sensor built into an Apple Watch strap, as well as an Apple Watch app on which users can see their ECG in near real-time.

"If you can direct them when to do the EKG it's going to markedly increase the number of EKGs taken". Moreover, other heart irregularities like irregular heartbeats, sinus tachycardia, and atrial fibrillation can also be detected. The accompanying Apple Watch application then processes the data. "It's one of the hardest things I've ever done in my life", Gundotra said.

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KardiaBand is available starting today for $199 and requires subscription to AliveCor's Premium service for $99 a year. Powered by an internal lithium battery with a lifetime of 1-2 years, the sensor in KardiaBand is always ready to use - with the recording screen open on your Apple Watch, simply touch your index finger to the KardiaBand sensor to start a recording.

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