tardily last month , Fitbitthrew a Hail Mary — and pulled it off — when the wearables company unveiled its fall card . At the pith of was a newSense smartwatch , which among other snazzy features has the power to take electrocardiogram reading to supervise for atrial fibrillation — pending clearance from the U.S. Food and Drug Administration , of course . Well , it ’s not pending anymore . Fitbitannouncedtoday that the FDA has turn over the go - ahead for the Sense ’s ECG app .
This is pretty large 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 party essay to succeed courting , but none were capable to win headroom from the FDA , though not for lack of try . Withings had applied for clearance for itsMove ECGsmartwatch , and Samsung introduced ECG capability on itsGalaxy Watch Active2 . It ’s indecipherable why those company have n’t welcome clearance , but to this solar day , the Apple Watch is still the only smartwatch on the marketplace with that feature enabled — until the Sense startle shipping .
https://gizmodo.com/fitbit-just-made-a-wildly-advanced-smartwatch-that-im-f-1844828208
Image: Fitbit
Not only has Fitbit receive 510(k ) clearance from the FDA , it ’s also received clearance from Europe ’s Conformité Européenne ( CE ) . While the ECG app wo n’t participating when the watch goes on cut-rate sale later this month , the wait wo n’t be too long . Fitbit enjoin 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 matter , 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 in the beginning 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 boundary among outside Android users not bad 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 potentiality . )
To get clearance , Fitbit had to conduct a “ multi - site clinical trial in part across the U.S. ” The result of thatstudypurportedly showed Fitbit ’s algorithm was able to observe 98.7 % of aFib subject and 100 % accuracy in identifying people with normal sinus rhythm . afford that more than 400,000 participant were included in that bailiwick , that ’s a pretty encouraging result .
Honestly , it ’s exciting that the ECG app on the Fitbit Sense will be uncommitted to try so presently after the watch ship . Typically , as we saw with Withings and Samsung , sometimes these advanced lineament 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 stack up against Apple and Samsung ’s . But look at that U.S. Android users have already had to look nearly two age for an ECG smartwatch , what ’s a few additional week ?
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