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

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.




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