Fitbit’s PPG algorithm gains FDA clearance

Fitbit’s PPG algorithm has gained US FDA approval

Fitbit has received clearance from the US Food and Drug Administration (FDA) for a new photoplethysmography (PPG) algorithm to identify atrial fibrillation (AF). The algorithm will power a new irregular heart rhythm notification feature on Fitbit.

In a press release, Fitbit said that the new PPG AF algorithm can passively assess the heart rhythm of a device user in the background while they are still or asleep, and if there are any signs suggestive of AF, the user will be notified.

The clinical validation for Fitbit’s PPG algorithm is supported by data from the Fitbit Heart Study, which launched in 2020 and enrolled 455,699 participants over five months. The study was conducted entirely virtually during the pandemic, making it one of the largest remote studies of PPG-based software to date, according to the Fitbit press release. Data presented at the American Heart Association’s Scientific Sessions 2021 (AHA 2021; 13–15 November; virtual) found that the Fitbit PPG detections identified AF episodes 98% of the time, as confirmed by ECG patch monitors.

The Fitbit PPG-based algorithm and irregular heart rhythm notifications feature will soon be available to consumers in the USA across a range of heart-rate enabled devices.

“We want to make AF detection as accessible as possible to help reduce the risk of potentially life-threatening events—like stroke—and ultimately improve overall heart health for everyone,” the company’s release states. “We will continue to work with the BMS-Pfizer Alliance to develop educational content for patients and healthcare providers that will help identify and support people in the USA with irregular heart rhythms consistent with atrial fibrillation.”


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