Fitbit gets US FDA clearance for passive heart rhythm monitoring

fitbit heart

A Fitbit feature that passively monitors users’ heart rhythms was cleared by the US’s Food and Drug Administration, the company announced today.

AFib is a form of irregular heart rhythm that affects nearly 33.5 million people globally, and individuals with AFib have five times higher risk of stroke. Unfortunately, AFib can be difficult to detect as there are often no symptoms and episodes can come and go.

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

See https://www.theverge.com/2022/4/11/23020143/fitbit-google-fda-clearance-heart-rhythm-afib

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