Fitbit’s ECG app gets regulatory clearance in U.S. and European Union

The ECG app can detect over 98% of atrial fibrillation cases and was 100% accurate in identifying participants with normal sinus rhythm, according to study results.
By Mallory Hackett
11:44 am

Fitbit’s new electrocardiogram app has officially received regulatory clearance in the U.S. and European Union for its latest smartwatch, the Fitbit Sense, to monitor heart rhythm and detect atrial fibrillation.

Now that the app has 510(k) clearance from the U.S. Food and Drug Administration and CE marking, Fitbit Sense users can access the ECG app beginning in October.

The company conducted a clinical trial to assess the ECG algorithm’s ability to accurately detect atrial fibrillation from normal sinus rhythm and to create a recording of the heart’s electrical rhythm. The study’s results demonstrated the algorithm could detect over 98% of atrial fibrillation cases and was 100% accurate in identifying participants with normal sinus rhythm.

Wearable ECG sensors like this give people a way to take on-the-spot readings of their heart rhythm at any time. To use FitBit’s app, users hold their fingers to the stainless steel ring on the watch and stay still for 30 seconds while the watch conducts a reading that can be shared with a doctor.


Cardiovascular disease is the leading cause of death globally, according to Our World in Data. The American Heart Association estimates that someone dies of CVD every 37 seconds in the U.S. and that there are more than 2,300 deaths from CVD each day, based on 2017 data.

Despite being so common, CVD is largely preventable. The World Health Organization says 80% of premature heart disease and stroke could be prevented.

Atrial fibrillation is the most common cardiac arrhythmia and often results in significant clinical events and costs, according to research in the Journal of Thoracic Disease. However, in at least one-third of patients, it doesn’t have symptoms and sometimes isn’t found until after complications such as stroke or heart failure. Newly developed ECG technologies offer a way for physicians to diagnose diseases early to prevent future complications, the research said.


In August, Fitbit announced the launch of its new range of products that included the Fitbit Sense, Fitbit Versa 3 and Fitbit Inspire 2. The announcement of the Fitbit Sense smartwatch marked the company’s first device compatible with an ECG app.

Fitbit had been working on adding heart rhythm tracking capabilities for some time through its heart study. It now enters the ECG space after competitors Apple and Withings previously added similar features to their respective watches.

In other wearable news, Amazon released its first health tracker, called the Amazon Halo. Notable features for its device include activity and sleep tracking, body fat percentage measurements and voice-recorded tone assessments.


“Helping people understand and manage their heart health has always been a priority for Fitbit, and our new ECG app is designed for those users who want to assess themselves in the moment and review the reading later with their doctor,” said Eric Friedman, Fitbit cofounder and CTO, in a statement. “Early detection of AFib is critical, and I’m incredibly excited that we are making these innovations accessible to people around the world to help them improve their heart health, prevent more serious conditions and potentially save lives.”


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Person in a telemedicine visit at home

(Photo credit: Alistair Berg/Getty Images) 

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(Photo Credit: Kwanchai Lettanpunyaporn/Getty Images) 



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