Fitbit (NYSE:FIT) today announced it received FDA clearance for its photoplethysmography algorithm to identify atrial fibrillation.
The consumer electronics company 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 records an electrocardiogram trace to allow 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.
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.
The company said the PPG-based algorithm and irregular heart rhythm notification feature will be available to consumers in the U.S. in the coming months for a range of heart-rate enabled devices.