​Fitbit Sense ECG clears FDA ahead of launch

And it will be ready on the Sense in October
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Fitbit has received clearance for the use of its ECG app in the US and Europe, ahead of the launch of the Fitbit Sense.

The Fitbit Sense is the company’s first health watch and is set to be released on 25 September, and debuts the use of electrocardiogram on a Fitbit device.

And Fitbit says that the feature will land on the Fitbit Sense in October 2020, in the US and UK as well as most European countries and India.

Fitbit validated its ECG feature in multiple, local studies across the globe. According to the study it was able to detect Afib in 98.7% of cases, and was 100% accurate in identifying study participants with normal sinus rhythm.

Afib is the leading cause of strokes in the US, so catching an irregular rhythm early can be a life-saver.

On the Fitbit Sense you can take a spot ECG reading, which will detect whether you have a normal or Afib rhythm. You can also share the results with your doctor.

We’ve seen ECG feature on Apple, Samsung and Withings devices. Samsung has received FDA clearance for use on the Galaxy Watch 3, but has not released the feature to consumers.

But FDA approval has nuked Withings devices, with both the Move ECG and ScanWatch unreleased in the US.

It’s great news for Fitbit. The Fitbit Sense certainly has us excited with its focus on stress, the use of an EDA sensor, and new data from breathing rate, temperature, heart rate variability, ECG and more.

The new focus on wellness, as well as fitness, is a potent mix, so it’s great that we won’t have to wait long to get the full suite of features.


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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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