Google asks FDA to clear Fitbit for passive heart rhythm monitoring

Google asks FDA to clear Fitbit for passive heart rhythm monitoring

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Google submitted information for a caller Fitbit diagnostic that would passively show users’ bosom rhythms to the Food and Drug Administration, the institution announced today.

Fitbit currently tin lone cheque for irregular bosom bushed periodically; users person to actively determine to instrumentality a reading. The caller diagnostic would tally successful the inheritance and alert radical if they’re showing signs of a information called atrial fibrillation. It’d bring Fitbit’s EKG diagnostic person to the 1 connected the Apple Watch, which checks the wearer’s bosom rhythms connected juncture and alerts them if it catches immoderate irregularities.

Fitbit launched a study successful 2020 to trial its passive bosom bushed technology. Nearly fractional a cardinal Fitbit users participated successful the study, and it flagged astir 1 percent of participants (just nether 5,000 people) arsenic having an irregular bosom rhythm, according to information presented astatine the 2021 American Heart Association meeting. Those radical were asked to acceptable up a telehealth consultation truthful they could get an EKG patch, and astir 1,000 did so. Of that group, a 3rd had the diagnosis confirmed — giving the tech a affirmative predictive worth for atrial fibrillation of 98 percent. (For comparison, the Apple Watch atrial fibrillation alert had a affirmative predictive worth of 84 percent connected a similar-sized study.)

“These results are highly promising and we deliberation volition person a existent interaction connected aboriginal detection and attraction of this important condition,” Tony Faranesh, a probe idiosyncratic astatine Fitbit, said successful a property briefing.

Atrial fibrillation is associated with a higher hazard of stroke, and the anticipation is that this benignant of aboriginal detection volition assistance forestall stroke. But it’s inactive unclear if monitoring for atrial fibrillation via smartwatch volition really support strokes from happening — astir probe focuses connected whether devices are accurate, not whether utilizing them keeps radical healthier successful the agelong run.

Faranesh said determination isn’t a wide timeline for erstwhile the caller diagnostic mightiness beryllium disposable connected Fitbit devices.

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