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FDA clears Fitbit’s irregular rhythm notifications software

US Food and Drug Administration has cleared Fitbit’s Irregular Rhythm Notifications software intended to be used with certain wrist-worn consumer products to analyze pulse rate data and identify episodes of irregular heart rhythms that may suggest possible atrial fibrillation. Fitbit’s Irregular Rhythm Notifications software is designed to notify the user when an irregular heart rhythm occurs while the user is not moving. It is intended for over-the-counter use. It is not intended to diagnose or treat atrial fibrillation; for use in people under 22 years of age; or for use in individuals previously diagnosed with atrial fibrillation.

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