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

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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, and should get clearance before December.

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,” a 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 use in South Korea, and has passed the FDA in the US, but there’s not a 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 has still not cleared the FDA.

And 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.

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