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Fitbit’s Sense smartwatch gets FDA clearance for EKG app

Fitbit’s Sense smartwatch gets FDA clearance for EKG app


It’s the third smartwatch in the US with an EKG app

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Fitbit Sense
Image: Fitbit

The heart-monitoring electrocardiogram (EKG) app on Fitbit’s new Sense smartwatch has been cleared by the US Food and Drug Administration (FDA). The feature can track heart rhythms and look for signs of atrial fibrillation, the most common type of irregular heartbeat.

“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, co-founder and chief technology officer at Fitbit, in a statement.

Atrial fibrillation puts people at increased risk for stroke and other heart conditions. Wearable devices can monitor people continuously throughout the day and may be able to flag a problem a traditional heart monitor (which only measures heart rate at specific time points) might miss.

This is the third wearable app to get FDA clearance for an EKG feature. The Apple Watch was the first in 2018, and Samsung announced that it received the designation at its Unpacked event in early August.

Because these types of devices are considered low risk, they don’t go through a formal approval process, which requires extensive testing. The FDA signed off on the Sense through a pathway that asks companies to show that their new device is similar to products that are already on the market.

The clearance came through in time for the Sense’s planned launch date at the end of the month. Other companies haven’t been so lucky: Samsung first built an EKG feature into last year’s Galaxy Watch Active 2, but it didn’t get clearance to activate it in the US at the time. It’s not clear if or when people with that version in the US will be able to use it. The updated Galaxy Watch 3 has the app, but Samsung hasn’t said when it’ll be available to US users. Withings has two smartwatches with EKG features, but it doesn’t have FDA clearance, so neither can be sold in the US. (They’re available in Europe.)

Fitbit ran a small study of its software last year, which found that it could accurately detect 98.7 percent of atrial fibrillation cases. In May, the company announced it would run a larger study to keep evaluating how well its devices can identify atrial fibrillation. Fitbit will follow up with anyone in the study with an irregular heartbeat and connect them with a physician, who will check to see if they actually have the condition. The study aims to enroll hundreds of thousands of participants.