Google’s Fitbit Is Granted FDA’s 510(k) Clearance for its AFib Detection Feature

Google has received the FDA’s 510(k) marketing clearance for a new Fitbit algorithm used to identify atrial fibrillation (AFib).

The PPG (photoplethysmography) algorithm can monitor the heart rhythm in the background while the user is still or asleep. If it detects anything that might be AFib, it notifies the user so they can follow up with their healthcare provider.

The clearance was supported by data from a virtual study that included 455,699 participants, which showed that the algorithm correctly identified AFib episodes 98 percent of the time, as confirmed by ECG patch monitors.

Google said it plans to make the new feature available in the U.S. across a range of heart-rate enabled devices.