An app in Fitbit's latest smartwatch has received clearance from the Food and Drug Administration to detect atrial fibrillation, the wearables company said Monday.
The FDA granted the electrocardiogram app in Fitbit's Sense smartwatch, which the company launched last month, 510(k) clearance for its ability to take a point-in-time reading of the wearer's heart rhythm, which the app analyzes for signs of an irregularity known as atrial fibrillation. The smartwatch retails for $329.95.
After taking an ECG reading, users can download the reading and share it with their physician, according to Fitbit.
Fitbit submitted results from a multisite U.S. clinical trial to the FDA as part of the recent clearance process, finding that the algorithm used in the ECG app accurately detected 98.7% of atrial fibrillation cases and 100% of cases with normal sinus rhythms. The study evaluated the app's ability to accurately detect atrial fibrillation at a point in time, which the company calls a "spot check."
Fitbit is still studying whether the ECG app can identify asymptomatic atrial fibrillation by screening a wearer's heart rhythm regularly, rather than at a single point in time.
"Helping people understand and manage their heart health has always been a priority for Fitbit, and our new ECG app is designed for those users who want to assess themselves in the moment and review the reading later with their doctor," said Eric Friedman, Fitbit co-founder and chief technology officer, in a statement.
To validate the app's ability to identify episodes of irregular heart rhythm over a long-term period, Fitbit in May launched a study dubbed the Fitbit Heart Study. So far, it has enrolled more than 400,000 participants.
The study will be used as part of Fitbit's FDA submission for the long-term heart rhythm assessment feature.
Fitbit in November announced plans to be acquired by Google for an estimated $2.1 billion, though the companies are awaiting regulatory approval.
Wearables companies, traditionally focused on the direct-to-consumer wellness market, have increasingly been looking at ways their devices can be used by clinical teams to inform care and encourage patients to proactively manage their health.
Amazon last month unveiled the Amazon Halo, a health gadget being implemented at Sharp HealthCare in San Diego.
Apple made waves in the digital health world in 2018 when it announced its new Apple Watch would offer an FDA-cleared ECG app, becoming the first major consumer wearables company to offer the capability. At the time, some physicians expressed concerns about the device, such as that its constant screening could prompt unneeded medical visits among healthy patients.