Fitbit Cleared by FDA for Afib Detection

April 11, 2022

The US Food and Drug Administration (FDA) has approved Fitbit’s algorithm for passive round the clock atrial fibrillation (afib) detection. The algorithm, validated in a 2020 study, uses photoplethysmography (PPG)  sensor technology, much like the technology used by the Apple Watch, which was approved by the FDA for detecting afib.

According to Andrea Park of Fierce Biotech, “In its announcement about the FDA clearance, Fitbit highlighted the algorithm’s far-reaching potential, singling out statistics showing that while often difficult to detect, afib affects as many as 33.5 million people around the world and ups their risk of stroke five times over.”

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(Source: Fierce Biotech, April 11th, 2022)

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