Fitbit Sense smartwatch receives U.S. and EU clearance for its ECG app

Fitbit has obtained clearance from the U.S. Food and Drug Administration (FDA) and the European Union's Conformité Européenne for the electrocardiogram (ECG) app on the Fitbit Sense smartwatch, which was unveiled last month. The company announced today that the app will be available on the Sense in October.

The app is designed to analyze heart rhythms and detect signs of atrial fibrillation (AFib) of users from their wrist. AFib is an irregular heart rhythm that can lead to an increased risk of stroke and other heart conditions. Fitbit noted that this condition affects more than 33.5 million people worldwide.

Eric Friedman, Fitbit Co-founder and Chief Technology Officer, said:

“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 docto. 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.”

As part of its submission process, Fitbit conducted clinical trials at multiple sites across the U.S. with the goal of evaluating how the app's algorithm would detect AFib from normal sinus rhythm and to track a heart’s electrical rhythm. Based on the results, the algorithm spotted 98.7% of AFib cases and achieved 100% accuracy in identifying study participants with normal sinus rhythm.

Countries where the app will be rolled out include the US, UK, Germany, Austria, Luxembourg, the Netherlands, Sweden, Switzerland, Czech Republic, Poland, Belgium, Portugal, Romania, Ireland, Italy, Spain, France, Hong Kong, and India.

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