Fitbit’s ECG app cleared for sale in the U.S. and EU

Fitbit has earned regulatory clearance in the U.S. and the EU for an electrocardiogram (ECG) app that detects atrial fibrillation, or AFib – an irregularity of the heartbeat that can increase the risk of a stroke. Specifically, the device has received 510(k) clearance from the U.S. Food and Drug Administration ...

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