Fitbit's ECG app gets FDA nod to track heart rhythm irregularities

Getting up to speed with competitor Apple, Fitbit has gained medical device clearances in the U.S. and Europe for its smartwatch electrocardiogram app.

The wearables giant announced Monday its ECG app got a green light from the U.S. Food and Drug Administration (FDA) and the EU's CE mark. The regulatory approvals open up the capability for its ECG app to track users' heart rhythms for signs of atrial fibrillation.

It follows in the footsteps of the Apple Watch receiving FDA clearance in 2018 for its ECG feature. Samsung got an FDA nod in August for its ECG monitoring app as part of the Galaxy Watch 3.

Amazon also recently jumped into the wearables space with its Amazon Halo fitness tracker. That device, which does not offer heart rhythm tracking, monitors activity and sleep trends and has tools to measure body fat and tone of voice as an indicator of overall well-being.

Google is in the process of acquiring Fitbit, which now has 30 million active users, for $2.1 billion. The deal still needs to be approved by regulators.

Fitbit unveiled the ECG app as a feature on its newest device, Fitbit Sense, which will be available in October.

The Fitbit Sense is designed to track key trends in users' health and well-being such as heart rate variability, breathing rate and blood-oxygen saturation, or SpO2, according to the company. The device also will have an on-wrist skin temperature sensor that can help detect potential signs of illness.

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The new Fitbit ECG app is designed for those users who want to assess themselves for afib in the moment and review the reading later with their doctor, according to Eric Friedman, Fitbit co-founder and chief technology officer.

Heart disease continues to be the leading cause of death worldwide, despite being one of the most preventable conditions. Afib, an irregular heart rhythm that increases the risk of serious complications like stroke, can be particularly difficult to detect, as episodes can sometimes show no symptoms. Some studies suggest that as many as 25% of people who have an afib-related stroke find out they have afib only after a stroke has occurred, according to the company.

As part of the approval process, Fitbit conducted a multisite clinical trial in the U.S. to evaluate its algorithm's accuracy in detecting afib from normal sinus rhythm and generating an ECG trade, or recording of the heart's electrical rhythm.

The study showed the algorithm exceeded target performance, detecting 98.7% of afib cases. It was also 100% accurate in identifying people with normal sinus rhythm, Fitbit said.

Physicians often are not aware of the day-to-day lives of patients in between office visits. Wearable devices hold the promise of helping physicians stay better connected and use real-world, individual data to deliver more informed, personalized care, according to Venkatesh Raman, M.D., an interventional cardiologist at MedStar Georgetown Hospital and principal investigator for the U.S. clinical study on Fitbit’s ECG app.

"Given the toll that AFib continues to take on individuals and families around the world, I’m very enthusiastic about the potential of this tool to help people detect possible AFib, a clinically important rhythm abnormality, even after they leave the physician’s office," Raman said.

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In May, Fitbit launched a large-scale study to validate the use of its technology to detect afib using data from its millions of Fitbit device users. In just over four months, the Fitbit Heart Study has enrolled more than 400,000 participants, the company said.

It's part of Fitbit's broader ambitions in healthcare to use its wearable technology for preventive health to reduce the risk of life-threatening events like stroke by detecting problems earlier. 

The new ECG app is part of Fitbit’s broader approach to heart health innovation, Friedman said.

The company's focus on healthcare, along with its work in clinical trials to alert users to conditions like hypertension and sleep apnea, makes it clear that it wants to pivot its wearables from just fun accessories to health devices. 

Scripps Research Institute and Stanford Medicine are collaborating with Fitbit on research aimed at using Fitbit data to help detect, track and contain infectious diseases like COVID-19.