FDA Approves First Apple Watch EKG Band

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The Watch's sensor calculates heart rate and rhythm using green LED lights that flash hundreds of times per second.

The Kardia Band is sort of like an improvement over the company's KardiaMobile device. If the app determines that your heart rate is abnormal, it will prompt you to take another EKG reading. Using this method, the Apple Heart Study app can identify an irregular heart rhythm.

Later, the same eHealth study concluded the Watch could also detect sleep apnea and hypertension with similar accuracy using its built-in sensor.

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"Apple might be able to say "oh your heart rate is high" ...but what does that mean?" As for how the app would work - you just install it and set it up, then go about your day. More advanced software to take your pulse were a major addition to Apple's latest Watch software upgrade, and users can already get alerts when you appear to have an elevated heart rate but aren't active. "Any doctor will say "ok come in, lets get an EKG reading", Gundotra told TechCrunch. "Today, EKGs are available only in offices and hospitals, using complex equipment, and usually only after a life-threatening event, for example a stroke". They will still need electrocardiograms to diagnose atrial fibrillation. "That is a big, big play".

As with the Apple Heart Study, AliveCor's rollout is targeted at detecting AFib early, before it progresses to a serious health issue. In our initial studies Apple Watch has been effective at surfacing irregular rhythms. However, Tim Cook has stated in the past that Apple doesn't want the Watch itself to be subject to FDA approval as that could slow down the pace of development.

The KardiaBand from AliveCor uses a neural network to predict and analyze the wearer's heart rate based on his or her history and a trove of cardiovascular data from both sick and healthy people.

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That's an important marker for the company.

Atrial fibrillation, which affects millions worldwide, is the leading cause of stroke. Apple already employs a small staff of medical professionals to develop its health products, and it is reportedly working on a diabetes glucose-monitoring device that won't pierce the skin. "Yet the FDA has cleared our individual algorithms", Gundotra said. "It's one of the hardest things I've ever done in my life", Gundotra said. We've been looking at this for a couple years and we think Apple Watch can help.

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.

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