Fitbit Sense's ECG App Is Now FDA-Cleared, Just Like the Apple Watch

Illustration for article titled Fitbit Senses ECG App Is Now FDA-Cleared, Just Like the Apple Watch
Image: Fitbit

Late last month, Fitbit threw a Hail Mary—and pulled it off—when the wearables company unveiled its fall lineup. At the center of was a new Sense smartwatch, which among other snazzy features has the ability to take electrocardiogram readings to monitor for atrial fibrillation—pending clearance from the U.S. Food and Drug Administration, of course. Well, it’s not pending anymore. Fitbit announced today that the FDA has given the go-ahead for the Sense’s ECG app.

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This is pretty big news in the wearables game. Apple was the first to get de novo FDA clearance for an ECG app on a smartwatch with the Apple Watch Series 4 in 2018. Other companies attempted to follow suit, but none were able to win clearance from the FDA, though not for lack of trying. Withings had applied for clearance for its Move ECG smartwatch, and Samsung introduced ECG capability on its Galaxy Watch Active2. It’s unclear why those companies haven’t received clearance, but to this day, the Apple Watch is still the only smartwatch on the market with that feature enabled—until the Sense starts shipping.

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Not only has Fitbit received 510(k) clearance from the FDA, it’s also received clearance from Europe’s Conformité Européenne (CE). While the ECG app won’t active when the watch goes on sale later this month, the wait won’t be too long. Fitbit said the feature will go live in October and will be available in the U.S., UK, Germany, Austria, Luxembourg, the Netherlands, Sweden, Switzerland, Czech Republic, Poland, Belgium, Portugal, Romania, Ireland, Italy, Spain, France, Hong Kong, and India.

That’s a long list of countries! Which is a good thing, especially when you consider Samsung Galaxy Watch 3's ECG app is, at this moment, only live in South Korea. While Samsung did get FDA approval during its Unpacked Event earlier this month, the feature has yet to make its way to compatible Galaxy Watches in the U.S. This could give the Fitbit Sense a slight edge among international Android users keen to try the ECG feature. (The Withings Move ECG has had CE clearance, but it’s also a hybrid analog watch that lacks some more advanced capabilities.)

To get clearance, Fitbit had to conduct a “multi-site clinical trial in regions across the U.S.” The results of that study purportedly showed Fitbit’s algorithm was able to detect 98.7% of aFib cases and 100% accuracy in identifying people with normal sinus rhythms. Given that more than 400,000 participants were included in that study, that’s a pretty encouraging result.

Honestly, it’s exciting that the ECG app on the Fitbit Sense will be available to try so soon after the watch ships. Typically, as we saw with Withings and Samsung, sometimes these advanced features can take months if not years before they’re cleared for consumers, even if the hardware is all there. We’ll have to wait a bit before we can see how the Fitbit Sense’s ECG app stacks up against Apple and Samsung’s. But considering that U.S. Android users have already had to wait nearly two years for an ECG smartwatch, what’s a few extra weeks?

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Consumer tech reporter by day, danger noodle by night. No, I'm not the K-Pop star.

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DISCUSSION

So, if it detects aFib, does it light up or buzz or in some manner notify the wearer? Not everyone is aware of brief episodes of aFib but duration and frequency are important indicators of a problem. You can’t have a system that floods the doctor’s office with rhythm strips.