MobiHealth News September 14, 2020
The ECG app can detect over 98% of atrial fibrillation cases and was 100% accurate in identifying participants with normal sinus rhythm, according to study results.
Fitbit’s new electrocardiogram app has officially received regulatory clearance in the U.S. and European Union for its latest smartwatch, the Fitbit Sense, to monitor heart rhythm and detect atrial fibrillation.
Now that the app has 510(k) clearance from the U.S. Food and Drug Administration and CE marking, Fitbit Sense users can access the ECG app beginning in October.
The company conducted a clinical trial to assess the ECG algorithm’s ability to accurately detect atrial fibrillation from normal sinus rhythm and to create a recording of the heart’s electrical rhythm. The study’s results demonstrated the...