FDA green-lights Fitbit’s AFib detection algorithm designed for longer-term tracking

This morning Fitbit got the FDA license for the long wait algorithm to detect atrial fibrillation by photoplethysmography (AFib). The algorithm will be part of Fitbit’s new Abnormal Heart Rate Alert feature, which is designed to alert users to potential AFib.

The technology can run passively on a Fitbit wearable and gauge heart rate while a person is sleeping or not moving. Users who suspect AFib will receive a message recommending they see a healthcare professional.

“As your heart beats, small blood vessels throughout your body dilate and contract based on changes in blood volume,” the Fitbit team wrote on the blog announcing the clearance.

“Fitbit’s PPG optical heart rate sensor can detect these volume changes right from your wrist. These measurements determine your heart rate, then the detection algorithm analyzes the signatures. abnormalities and potentialities of atrial fibrillation.”

Users have previously been able to use Fitbit’s ECG app for spot check assessments. This new clearance allows for an alternative approach, using PPG-based algorithm for long-term heart rate assessment. According to the company’s announcement, the new feature and algorithm will be available in the US soon

In March, the company announced that it had submitted its AFib detection algorithm to the FDA. At the same time, the company also emphasized Fitbit Heart Studylaunched in 2020 with results released late last year. Research presented at American Heart Association Scientific Sessionsfound that Fitbit PPG detection was able to correctly identify AFib episodes 98% of the time.


According to Mayo Clinic, AFib can increase a patient’s risk of stroke, heart failure, and other heart-related complications. The health system reports that AFib by itself is not usually fatal, but it requires treatment to prevent a stroke.

Fitbit is touting its technology as a way to help users spot potential AFib.

“AFib is a form of irregular heart rhythm that affects nearly 33.5 million people globally, and people with AFib are five times more likely to have a stroke. Unfortunately, AFib can be difficult to detect because it is often absent. Symptoms and attacks can come and go,” Fitbit wrote in a release.


It’s no secret that wearable companies are looking to expand their reach into cardiovascular healthcare. In 2018, Apple became the first consumer technology company the company launched a Electrocardiogram feature.

Fitbit soon after in 2020, landing regulatory clearance in the United States and European Union for Fitbit Sense to monitor heart rate and detect atrial fibrillation. Other companies include Withings and SAMSUNG also added ECG features.

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