Fitbit gets FDA clearance for passive heart rate monitoring

A Fitbit feature that passively monitors users’ heart rates has been cleared by the Food and Drug Administration, the company announced today.

The feature periodically checks wearers’ heartbeats and alerts them if they have signs of atrial fibrillation, a type of irregular heartbeat that puts people at higher risk of stroke. Fitbit already had an FDA-approved EKG app that can perform spot checks for the condition, but users had to manually take those readings. The new tool runs in the background.

Fitbit conducted a study testing the feature in 2020, which found the technology could correctly identify cases of atrial fibrillation 98% of the time. Adding this tool to Fitbit devices brings its heart monitoring technology more in line with the Apple Watch, which also passively scans wearers to try to identify heart rhythms that suggest someone might have atrial fibrillation. Neither device can make a diagnosis, but they do flag potential issues that someone could talk to their doctor about.

The Fitbit team said in a blog post that passive atrial fibrillation could “help reduce the risk of life-threatening events — like stroke — and ultimately improve overall heart health for everyone.” That’s the hope of this type of device – that it could help people detect atrial fibrillation early so they can take steps to monitor their heart health more closely. But it’s still unclear if these kinds of features actually protect people’s health.

Fitbit said the new feature will soon be available to users in the United States.


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