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FDA Approves EKG Heart Monitor for Apple Watch

A company called AliveCor just managed to get the first medical-grade Apple Watch accessory approved by the FDA. You might know the CEO of AliveCor -- it's none other than former Googler Vic Gundotra.
By Ryan Whitwam
kardia

Apple pitched the Apple Watch not only as a companion for your phone, but as a way to track your personal health stats throughout the day. A smartwatch might be fine for personal step counting and heart rate analysis, but it's hard to get approval from regulators to sell a wearable medical device. Now, a company called AliveCor just managed to get the first medical-grade Apple Watch accessory approved by the FDA(Opens in a new window). You might know the CEO of AliveCor -- it's none other than former Googler Vic Gundotra.

When he was at Google, Gundotra spent some time as the VP of engineering and the public face of the company at the yearly Google I/O conference. Gundotra eventually took over Google's social efforts with Google+ before leaving the company in 2014. Working in the medical device industry seems like a bit of a departure, but AliveCor is focused on using mobile technology in health care. Its first product was a standalone EKG device called KardiaMobile that pairs with iOS devices. Its new KardiaBand is basically a fancy watch band for the Apple Watch.

An EKG (or electrocardiogram) is a test that measures the electrical activity of the heart in order to diagnose cardiac abnormalities. Traditional EKGs rely on multiple electrodes placed on the patient's skin to measure the change in electrical potential. With the KardiaMobile, patients could press their fingers to a pair of contact pads on the pocket-sized device. With the KardiaBand, they only need to touch a sensor on the outside of the watch band to take a new reading.

The KardiaBand connects to the standard Apple Watch connector, then pairs with an app on the watch. It's understandably more bulky than most watch bands, though. The KardiaBand can take a reading in about 30 seconds to detect abnormal heart rhythms and atrial fibrillation (AFib). Data collected by the KardiaBand can be uploaded directly to your doctor for further analysis.

According to AliveCor, the KardiaBand is designed to learn from your stats and determine what an abnormal rhythm for you is. It calls this technology "SmartRhythm." The app may notify you on occasion to collect a full EKG readout if it detects an unexpected change in your heart rate as well.

AliveCor is offering the KardiaBand for $199, and it does basic analysis and detection of abnormal rhythms without a subscription. However, a premium subscription ($100 per year) is required for cloud storage, monthly reports, SmartRhythm, and more.

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