FDA approves EKG app for Apple Watch

AliveCor's Kardiaband EKG reader is the first medical device accessory approved by the agency for the Apple Watch.
By Brooks Hays  |  Nov. 30, 2017 at 2:21 PM
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Nov. 30 (UPI) -- Apple Watch wearers will soon be able to easily monitor the rhythm of their heart whenever and wherever they want.

That is if they buy AliveCor's Kardiaband EKG reader, the first medical device accessory for the Apple Watch to be approved by the Food and Drug Administration.

The previous iteration of the KardiaMobile device used a remote sensor linked to a smartphone, but the latest accessory inserts into the band of the Apple Watch. When the sensor is touched, it can capture an EKG reading in 30 seconds and differentiate between normal sinus heart rhythms and atrial fibrillation, the most common abnormal heart rhythm.

The medical device also includes a new feature called SmartRhythm, which taps into the Apple Watch's activity monitoring capabilities for correlations between heart activity and physical activity. The feature can identify anomalies or disconnects between the two.

"KardiaBand paired with SmartRhythm technology will be life-changing for people who are serious about heart health," Vic Gundotra, CEO of AliveCor, said in a news release. "These capabilities will allow people to easily and discreetly check their heart rhythms when they may be abnormal, capturing essential information to help doctors identify the issue and inform a clear path of care to help manage AFib, a leading cause of stroke, and other serious conditions."

Apple is one several technology companies chosen by the FDA to take part in a new digital health software precertification pilot program. The program was created to accelerate the development and production of health-tracking devices like Kardiaband.

While other health trackers are in the pipeline, it's not clear whether Apple itself will make their own devices and add-ons or simply partner with other companies. Apple CEO Tim Cook has reportedy been testing a glucose-tracking prototype himself.

Even when fast-tracking is made available, getting FDA approval isn't easy. Until now, getting an EKG reading could only happen at a hospital or doctor's office. Now, an accurate reading is at the fingertips of the average consumer.

"It's not possible to diagnose atrial fibrillation without FDA clearance," Gundotra told TechCrunch. "That is a big, big play."

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