Fitbit Sense smartwatch gets FDA approval for EKG features

Fitbit's upcoming Sense smartwatch will come with an EKG app.
Image: Fitbit

Smartwatches keep getting smarter with new health tracking features. A trendy one currently appearing in the market is heart-monitoring electrocardiogram (EKG) apps. Apple made a statement by baking the feature into its Apple Watch in 2018 and Samsung followed suit by getting its own approval last month.

Now, the other major player in the smartwatch world, Fitbit, is joining the party. It announced on Monday that its new Sense smartwatch’s EKG feature has been cleared by the U.S. Food and Drug Administration (FDA). It can track heart rhythms to identify dangerous patterns like atrial fibrillation (A-fib), which is the most common irregular heartbeat.

Better Third Than Never

It isn’t easy to include a full-fledged EKG monitor in a smartwatch. Of course, it isn’t as accurate as the machines used in hospitals, but it’s better than nothing.

Eric Friedman, co-founder and chief technology officer at Fitbit says, “Our new ECG [EKG] app is designed for those users who want to assess themselves in the moment and review the reading later with their doctor.”

Atrial fibrillation is a condition that’s often difficult to detect outside of the healthcare setting. When left untreated, it puts people at risk for stroke, blood clots, and more serious heart conditions.

Fitbit’s Sense smartwatch will be the third wearable device in the U.S. to get FDA clearance for an EKG app. It’s worth noting that Fitbit’s new smartwatch was approved through a pathway that asked the company to prove it is similar to other devices on the market.

Even so, in a small study last year, Fitbit found that its EKG software can accurately detect 98.7 percent of A-fib cases. It is also working on conducting a larger study consisting of hundreds of thousands of participants. That will be much easier once the Sense is in the hands of consumers who can opt-in to the study.

Staying Competitive

A wearables market that was relatively open just a few years ago is quickly growing more crowded. Companies like Fitbit, Apple, and Samsung are rolling out high-tech gadgets that users have come to love.

According to a 2019 survey by Pew Research Center, 21 percent of Americans regularly wear a smartwatch or fitness tracker. Although that’s a noteworthy figure, there is still plenty of room for the market to grow.

By including features like EKG tracking, Fitbit is keeping pace with its competitors.

The Fitbit Sense is scheduled to launch at the end of September. Of course, it remains to be seen if that will actually happen or if the release will be pushed back like so many other tech launches have been this year. In the past, other smartwatch manufacturers haven’t been lucky enough to get their devices approved in time. Samsung’s Galaxy Watch Active 2 launched last year but the feature couldn’t be activated until much later.

Fortunately for Fitbit, that won’t be an issue for the Sense. Keep an eye out for this smartwatch later this month to see how it compares to the current Versa 2 and upcoming Versa 3.


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