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FDA clears Fitbit device that passively monitors heart rhythms

FDA clears Fitbit device that passively monitors heart rhythms

An undated image of a Fitbit fitness tracker device. The Food and Drug Administration on Monday approved a feature on the device that passively monitors the heart rhythms of users. File Photo by A. Aleksandravicius/Shutterstock

April 11 (UPI) — The Food and Drug Administration on Monday cleared a Fitbit feature that passively monitors the heart rhythms of users.

The device periodically checks the rhythms of the heart of the person using it and alerts them if there is a sign of irregularity that puts people at risk for a stroke.

“Our new [photoplethysmography atrial fibrillation] algorithm can passively assess your heart rhythm in the background while you’re still or asleep,” Fitbit said in a statement.

“If there’s anything that might be suggestive of AFib, you’ll be notified through our Irregular Heart Rhythm Notifications feature — allowing you to talk with your healthcare provider or seek further assessment to help prevent a significant medical event, such as stroke.”

Fitbit said its clinical validation is supported by data from its 2020 heart study with 455,699 participants over five months. The data found that the Fitbit PPG detections correctly identified AFib episodes 98% of the time, confirmed by ECG patch monitors.

The American Heart Association also cited the research at its Scientific Sessions 2021 last November, a global exchange of the latest scientific advancements and research in cardiovascular science.

“Undiagnosed atrial fibrillation can lead to strokes, and early detection of atrial fibrillation may allow doctors to prescribe medications that are effective at preventing strokes,” Steven A. Lubitz, associate professor of medicine at Harvard Medical School, said then, pointing out the potential impact of the Fitbit device.

Fitbit said its algorithm can also detect AFib with its electrocardiogram app, which takes a spot-check approach.

“The Fitbit PPG-based algorithm and Irregular Heart Rhythm Notifications feature will soon be available to consumers in the United States across a range of heart-rate enabled devices,” Fitbit said.

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