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FDA Approves first Medical Devices Accessory for Apple Watch

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Published on : Nov 30, 2017

The Food and Drugs Administration (FDA) has just cleared KardiaBand, a wearable personal electrocardiogram (EKG) recorder, for use as a medical device accessory with the Apple Watch. The first such product to be approved by the FDA, the band has been specially designed by AliveCor for Apple Watch and is a variant of the KardiaMobile device, which itself was a FDA-approved medical grade EKG recorder made to be used by sticking it on the back of smartphones.

A version of the product was already available for use with Apple Watch in Europe for some time now. With the new FDA approval, the device will now also be sold in the U.S., marking the first time in the country that an Apple Watch accessary will be used as a medical device. The device allows users to record their EKGs discretely, at any place of choice to detect atrial fibrillation (AFib) and normal sinus heart rhythms in duration as small as 30 seconds. The device resembles a square slab that clicks into a slot on the band of the Apple Watch.

KardiaBand is capable of recording EKG just as the user touches the integrated sensor in the band. Results from the Kardia App are displayed on the screen of the Apple Watch. To support the new product, AliveCor has also introduced a new feature in the Kardia app – SmartRhythm. The new feature uses artificial intelligence in addition with the inputs from the heart rate and activity sensors in the Apple Watch to seamlessly evaluate the correlation between the users’ physical activity and heart activity.