FDA clears Fitbit for passive heart rhythm monitoring

Google has announced that the Food and Drug Administration (FDA) has cleared its product, Fitbit, to use a new feature that will identify atrial fibrillation (AFib). 

In a statement on Monday, Google said Fitbit’s new PPG AFib algorithm feature will assess users’ heart rhythms while they’re sleeping, adding that the new feature will alert users if they are suffering from AFib. This will give them time to notify their health care provider about their diagnosis, Google said. 

AFib is a form of an irregular heart rhythm that can be difficult to detect at first because there are no symptoms. About 33.5 million people suffer from this heart condition and individuals with this condition are five times more likely to suffer a stroke. 

“With today’s FDA clearance of our PPG-based algorithm, Fitbit now provides two ways to detect AFib. Fitbit’s ECG app, which takes a spot-check approach, allows you to proactively screen yourself for possible AFib and record an ECG trace that you can then review with a healthcare provider,” Google said in a statement. 

“Additionally, the new PPG-based algorithm allows for long-term heart rhythm assessment that helps identify asymptomatic AFib that could otherwise go undetected.”

Fitbit’s latest initiative was launched in 2020 as a clinical study and enrolled 455,699 participants. The study found that the device’s PPG detections correctly identified AFib episodes 98 percent of the time through participants, confirmed by its ECG patch monitors. 

Google noted that the new Fitbit feature will be available to U.S. consumers across a range of heart-rate enabled devices soon, adding it will continue to work with the BMS-Pfizer Alliance to develop educational content for patients and health care providers that will be useful for those suffering from AFib. 

The Hill has reached out to the FDA for comment and more information.