Published: Fri, December 01, 2017
Medicine | By Brett Sutton

FDA Approves EKG Heart Monitor for Apple Watch

FDA Approves EKG Heart Monitor for Apple Watch

The KardiaBand, the first medical device accessory approved by the US Food and Drug Administration for use with the Apple Watch, sells for US$199 (RM813). The accessory is AliveCor's KardiaBand electrocardiogram (EKG) reader, a sensor that pairs with an app and can detect abnormal heart rhythm and atrial fibrillation (AFib).

AliveCor CEO Vic Gundotra told TechCrunch that FDA approval is the difference between simply alerting you that your heart-rate is unusually high - which Apple is allowed to do - and providing an actual diagnosis.

Gundotra also outlined that it is a milestone for the company to only detect issues in heart but also obtain FDA approval to use sensor as a medical device. The app will evaluate the correlation between heart rate and activity, and if these appear abnormal, will alert the user to capture another EKG reading. AliveCor says that the app can also connect to Apple's Health app, so users can integrate their EKG readings into established fitness data like step count and weight. Having to stop and hold a button means you're technically not getting a fully accurate reading as you might if the Apple Watch itself were continually monitoring the same data. The accompanying Apple Watch application then processes the data. The Apple Watch's display shows the reading's data using a line graph that's similar to how the Apple Watch shows other heart rate data, and informs the user if their heart rate is normal or abnormal.

Tech Talk Apple Watches
Tech Talk Apple Watches

The FDA recently cleared AliveCor's electrocardiogram accessory for the Apple Watch, the Mountain View, Calif. -based company announced November 30. "Today, EKGs are available only in offices and hospitals, using complex equipment, and usually only after a life threatening event, for example a stroke". It's a watch strap called Kardiaband, it's made by a company called AliveCor, and it serves as an EKG reader for your wrist. The sensor can also test for atrial fibrillation (AFib), or irregular heartbeat, which affects 30 million people worldwide and one in four people over the age of 40. Atrial fibrillation is one of the leading causes of stroke. The work is created to identify Apple Watch users who might be in atrial fibrillation, and thus at increased risk for stroke. "Yet the FDA has cleared our individual algorithms".

"We were able to run a deep neural network on the Apple Watch and keep it to 14 hours of battery life on the new Series 3 Watch", Gundotra said. 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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