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Fitbit receives FDA and CE approval for the upcoming EKG app



Image for item titled Fitbit Senses EKG app is now FDA approved, as is the Apple Watch

image:: Fitbit

Late last month, Fitbit threw a hail Mary– and pulled it off –when the wearables company revealed his fall roster. In the middle of was a new one Sinn smartwatchwhich, among other things, has chic features the ability to take an electrocardiogram Measured values ​​for monitoring for atrial fibrillation – of course until they are approved by the US Food and Drug Administration. Well, it’s not pending anymore. Fitbit announced Today the FDA gave the go-ahead for the Sense EKG app.

That’s pretty big news in the wearables game. Apple was the first to get FDA approval for an EKG app on a smartwatch with the Apple Watch Series 4 in 2018. Other companies tried to follow suit, but none able to win FDA approval but fail for lack of attempt. Withings had requested clearance for his Move the ECG Smartwatch and Samsung have introduced the EKG function Galaxy Watch Active2. It’s unclear why these companies didn’t get approval, but to date the Apple Watch is the only smartwatch on the market activated with this function – until the scythe starts sending.

Fitbit just didn’t get it 510 (k) clearance from FDA, it’s also received Approval from the European Conformité Européenne (CE). The EKG app will not be active if the watch goes on sale later this monthThe wait won’t be too long. Fitbit said that The feature will go live in October and will be available in the US, UK, Germany, Austria, Luxembourg, the Netherlands, Sweden, Switzerland, the Czech Republic, Poland, Belgium, Portugal, Romania, Ireland, Italy, Spain, France and Hong Kong his and India.

That’s a long list of countries! Which is A good thing, especially considering that the Samsung Galaxy Watch 3’s EKG app is currently only available in South Korea. While Samsung received FDA approval during its Unpacked Event earlier this month, the feature has yet to find its way to compatible Galaxy Watches in the United States. This could give the Fitbit Sense a slight advantage with international Android users who want to try out the EKG function. (The Withings Move ECG is CE approved, but it is also a hybrid analog watch that lacks some advanced features.)

To get clearance, Fitbit had to conduct a “clinical study in multiple locations in regions in the US.” The results of it study reportedly showed Fitbit’s algorithm capable of detecting 98.7% of aFib cases and 100% accuracy in identifying individuals with normal sinus rhythms. Given that over 400,000 participants took part in this study, this is quite an encouraging result.

Honestly, it’s exciting that the The EKG app on the Fitbit Sense can be tested so soon after the watch is shipped. As we’ve seen with Withings and Samsung, these advanced features can sometimes take months, if not years, to be released to consumers, even with all of the hardware in place. We’ll have to wait a bit before we can see Fitbit Sense’s EKG app stack up against Apple and Samsung’s. But when you consider that US Android users almost had to wait 2 years What are a few extra weeks for an EKG smartwatch?


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