Heartbeat tracker becomes first FDA-approved medical device for the Apple Watch

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The FDA has approved an EKG monitor as an accessory for the Apple Watch - the first certified medical device for the increasingly popular wearable, medical tech company AliveCor announced Thursday.

The U.S. Food and Drug Administration on Thursday cleared a device embedded in an Apple Inc watch band that monitors a user's heart rate, detects when something is amiss and prompts the user to take an electrocardiogram.

KardiaBand, which is manufactured by medical artificial intelligence company AliveCor, is also introducing a new feature as part of the Apple Watch launch.

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If you want to keep a closer an eye on your heart health on your Apple Watch, the Kardia Band is now up for grabs for £199 with a KardiaGuard membership that unlocks monthly reports of your EKG readings setting you back £99 a year. 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. "Yet the FDA has cleared our individual algorithms", said Vic Gundotra, CEO, AliveCor.

"If your heart rate goes outside the predicted values of our deep neural network, we fire an alert that says "This would be a good time to take an ECG". Does that mean you should go to the hospital? "Any doctor will say "ok come in, let's get an EKG reading". This is a pretty solid development, considering that EKG machines are usually only available in doctors' offices and hospitals, and are mainly used after life-threatening events. Moreover, other heart irregularities like irregular heartbeats, sinus tachycardia, and atrial fibrillation can also be detected. "That is a big, big play". The real-time EKG waveforms are new-made possible by a change in the Watch Apple made at the request of AliveCor.

Apple has already well-established the fact that it wants the Apple Watch to be a cornerstone of modern, healthy lifestyles. However, it doesn't seem likely Apple would want to go through the hassle of FDA approval for the Watch, which is a general objective device used for numerous other applications besides getting your heart rate.

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AliveCor is also including a software feature known as SmartRhythm.

That's an important marker for the company. Atrial fibrillation is one of the leading causes of stroke.

"This is a medical device". This condition is the most common form of irregular heart beating, but it is twice more common among Americans. This is an FDA-cleared device. The KardiaBand makes this technology more discrete by making it into a tiny sensor that snaps into an Apple Watch band, making it accessible anywhere, anytime. Additional capabilities, like cloud storage, history and monthly reports sent to your doctor, cost $99 a year for Alivecor's premium subscription.

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