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Fitbit Receives Regulatory Clearance For ECG App To Identify Atrial Fibrillation (AFib)

September 14, 2020

Fitbit has received 510(k) clearance from the U.S. Food and Drug Administration, as well as Conformité Européenne marking in the European Union, for its electrocardiogram (ECG) app to assess heart rhythm for atrial fibrillation, a condition that affects more than 33.5 million people globally. The Fitbit ECG App will be available in October to users. Read more on SGB Media.