Fitbit received 510(k) clearance from the Food and Drug Administration for an electrocardiogram (ECG) app intended to detect atrial fibrillation. The regulatory milestone should help Fitbit as it continues to implement more health features into its devices.
Fitbit and competitor Apple have both designed tools to detect atrial fibrillation, an irregular heart rhythm that can increase the risk of some serious events, such as strokes. But it is frequently difficult to detect.
With Fitbit’s device, users can take a spot reading of their heart rhythm by holding their fingers to a stainless-steel ring around the watch face. They can download their reading and share it with a doctor.
As part of the regulatory process, Fitbit submitted data from a multi-site clinical trial showing its algorithm was able to detect 98.7% of atrial fibrillation cases and 100% of participants with normal heart rhythms.
Separately, the company recently launched a virtual study to evaluate the use of a PPG sensor for long-term heart rhythm assessment. Since May, Fitbit says more than 400,000 people have enrolled to participate in the study.
Apple, for its part, has launched a virtual study in conjunction with Johnson & Johnson to see if its atrial fibrillation detection feature can reduce stroke risk. Medicare patients with newer iPhones are eligible to participate in the randomized study.
Fitbit plans to include the feature in its newest device, Fitbit Sense, starting in October. The company is also cleared to sell the device in the European Union, where it received the CE marking for its device.