Google asks FDA to clear Fitbit for passive coronary heart rhythm monitoring

Google submitted information for a brand new Fitbit characteristic that might passively monitor customers’ coronary heart rhythms to the Food and Drug Administration, the corporate introduced as we speak.

Fitbit at present can solely verify for irregular coronary heart rhythm periodically; customers must actively determine to take a studying. The new characteristic would run within the background and alert folks in the event that they’re exhibiting indicators of a situation referred to as atrial fibrillation. It’d carry Fitbit’s EKG characteristic nearer to the one on the Apple Watch, which checks the wearer’s coronary heart rhythms once in a while and alerts them if it catches any irregularities.

Fitbit launched a study in 2020 to check its passive coronary heart rhythm expertise. Nearly half one million Fitbit customers participated within the research, and it flagged round 1 p.c of members (slightly below 5,000 folks) as having an irregular coronary heart rhythm, in response to information introduced on the 2021 American Heart Association assembly. Those folks had been requested to arrange a telehealth session so they might get an EKG patch, and round 1,000 did so. Of that group, a 3rd had the analysis confirmed — giving the tech a constructive predictive worth for atrial fibrillation of 98 p.c. (For comparability, the Apple Watch atrial fibrillation alert had a constructive predictive worth of 84 p.c on a similar-sized research.)

“These results are extremely promising and we think will have a real impact on early detection and treatment of this important condition,” Tony Faranesh, a analysis scientist at Fitbit, mentioned in a press briefing.

Atrial fibrillation is related to a better danger of stroke, and the hope is that one of these early detection will assist forestall stroke. But it’s nonetheless unclear if monitoring for atrial fibrillation through smartwatch will truly maintain strokes from taking place — most analysis focuses on whether or not gadgets are correct, not whether or not utilizing them retains folks more healthy in the long term.

Faranesh mentioned there isn’t a transparent timeline for when the brand new characteristic could be out there on Fitbit gadgets.