​Fitbit Sense ECG will clear FDA ‘before the holidays’

The ECG shouldn't be a long wait for Fitbit Sense users
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Fitbit has unveiled the Fitbit Sense with ECG, and has confirmed that users won’t have long to wait until the feature will be turned on.

ECG features need to be cleared by relevant regulatory bodies before they can be used, which can often mean long waits.

But Larry Yang told Wareable that ECG was in “final review” with the FDA, and that it would get clearance in the US and the EU “this side of the Holidays.”

Full details: Fitbit Sense health watch revealed

“Yeah, we are expecting it this side of the Holidays, but I can't tell you when,” another spokesperson confirmed.

That should give reassurance to anyone considering the Fitbit Sense that it won’t be a long wait for the feature to go live.

FDA approval can be a serious thorn in the side of wearable devices, and it took Fitbit years to turn on the SpO2 sensor to track blood oxygen.

The Apple Watch Series 4 launched a couple of months ahead of the release of its ECG feature, which launched in the US first and then made its way around the world.

The Samsung Galaxy Watch 3 has clearance for ECG in South Korea, and has passed the FDA in the US, but there’s no date on when the feature will arrive.

And spare a thought for Withings. The French company launched the Withings Move ECG in early 2019 and it has still not cleared the FDA.

Likewise, the Withings ScanWatch that was announced at CES 2020 is also stuck in limbo, waiting for both its sleep apnea and ECG features to be cleared.

The Fitbit Heart Study will have made it easier for the company to prove the accuracy of its ECG feature to the FDA.

But in an interview with Wareable, Withings CEO Mathieu Letombe explained how even small changes in clinical trials can set projects back:

“It can easily take six months to have the clinical study, the protocol to collect feedback from the medical community, in order to proceed with those with those clinical trials.

“So, it takes a lot of time, even if you just have to change a small thing in the in the protocol you have been using.

“This is where we are there is some back and forth it’s not just a simple response that you can get in one week, it's really building a new protocol and a new clinical study in order to demonstrate some specific kind of performances,” he said.

Watch this space for when the feature fully lands.


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James Stables


James is the co-founder of Wareable, and he has been a technology journalist for 15 years.

He started his career at Future Publishing, James became the features editor of T3 Magazine and T3.com and was a regular contributor to TechRadar – before leaving Future Publishing to found Wareable in 2014.

James has been at the helm of Wareable since 2014 and has become one of the leading experts in wearable technologies globally. He has reviewed, tested, and covered pretty much every wearable on the market, and is passionate about the evolving industry, and wearables helping people achieve healthier and happier lives.

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