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Fitbit’s ECG App Gets Clearance in U.S. and Europe for Assessing AFib

September 15, 2020

Fitbit has received both the FDA’s 510(k) clearance and a CE mark certification for its electrocardiogram (ECG) app for measuring heart rhythm for atrial fibrillation (AFib).

The company said the newly cleared ECG app will become available on its health smartwatch, Fitbit Sense, next month. The Sense includes a stress sensor, skin temperature sensor, a heart rate monitor and other features.

“The Fitbit ECG App may help prevent serious complications like stroke by allowing users to spot-check for signs of AFib from their wrist,” the company said.

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