ECG Kardia Band becomes first-ever FDA-approved medical device accessory for Apple Watch

The FDA has announced its approval of AliveCor’s Kardia Band, an electrocardiogram for use with the Apple Watch, marking the first authorisation of an accessory for the tech giant’s wearable as a medical device in the US.

 The technology originally took the form of KardiaMobile, a device which attaches to the back of a smartphone. Users would be required to hold their phone with both hands for 30 seconds to get a reading, which can be accessed via a companion app. However, with the authorisation of Kardia Band, the device itself slots into a space on the band of the Apple Watch, and by touching its integrated sensor a continuous reading can be achieved.

The Apple Watch is already recognised for its utility in monitoring health, having been used in clinical trials testing for abnormal heart rhythm, sleep apnoea and hypertension this year. A trial by the University of San Francisco and Cardiogram found the device to measure abnormal heart rhythm with 97% accuracy compared to an AI-based algorithm known as DeepHeart.

Being able to access an ECG reading at any time – a privilege one would normally need to visit a hospital for – could be key in helping to prevent and/or lower the risk of heart attack and stroke.

AliveCor Chief Executive Officer Vic Gundotra stressed the medical significance of ECG readings, telling TechCrunch: "Apple might be able to say ‘oh your heart rate is high’ […] but what does that mean? Does that mean you should go to the hospital? And if you go to the hospital what are they going to do? Any doctor will say ‘ok come in, let’s get an ECG reading’."