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Home » FDA clears Fitbit PPG algorithm to detect AFib

FDA clears Fitbit PPG algorithm to detect AFib

April 11, 2022 By Danielle Kirsh

FitbitGoogle’s Fitbit announced today that it received FDA clearance for its photoplethysmography algorithm to identify atrial fibrillation.

Fitbit — which Google’s parent company Alphabet (Nasdaq: GOOGL)
acquired early last year for $2.1 billion — said the PPG-based algorithm and irregular heart rhythm notification feature will be available to its U.S. consumers in the coming months. It will be included in a range of heart-rate enabled devices.

Google’s Fitbit team designed the photoplethysmography (PPG) algorithm to passively assess heart rhythm when the user is still or sleeping. It allows users to proactively screen for AFib and record an electrocardiogram trace for long-term heart rhythm assessment. If the Fitbit algorithm detects a heart rhythm indicative of AFib, the user will be notified through the company’s irregular heart rhythm notifications feature and can be reviewed by a healthcare provider.

AFib affects nearly 33.5 million people across the world, according to the National Institutes of Health. It can be difficult to detect as patients often have no visible symptoms of the heart condition. AFib usually isn’t life-threatening on its own, but it’s still serious because proper treatment is needed in order to prevent a stroke, according to Mayo Clinic.

Fitbit’s algorithm is supported by data from a landmark Fitbit Heart Study that was launched in 2020 and enrolled 455,699 participants in a five-month period. The data presented at the 2021 American Heart Association Scientific Sessions showed that Fitbit’s PPG detection algorithm detections correctly identified AFib episodes 98% of the time, as confirmed by ECG patch monitors.

 

Filed Under: 510(k), Business/Financial News, Cardiovascular, Diagnostics, Digital Health, Featured, Food & Drug Administration (FDA), News Well, Regulatory/Compliance, Software / IT Tagged With: Fitbit

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About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Design & Outsourcing, MassDevice, and Medical Tubing + Extrusion, and the founder of Women in Medtech and lead editor for Big 100. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at [email protected].

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