Fitbit Receives Regulatory Clearance in Both the United States and Europe for ECG App to Identify Atrial Fibrillation (AFib)
Fitbit (NYSE:FIT) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as Conformité Européenne (CE) marking in the European Union, for its electrocardiogram (ECG) app to assess heart rhythm for atrial fibrillation (AFib), a condition that affects more than 33.5 million people globally.1 The Fitbit ECG App, unveiled in Fitbit’s recent fall product launch, will be available in October 2020 to users on Fitbit Sense in the following countries: the United States, United Kingdom, Germany, Austria, Luxembourg, the Netherlands, Sweden, Switzerland, Czech Republic, Poland, Belgium, Portugal, Romania, Ireland, Italy, Spain, France, Hong Kong and India.2,3
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Fitbit Sense is the company’s first device compatible with an ECG app that enables users to take a spot check reading of their heart that can be analyzed for the heart rhythm irregularity atrial fibrillation. (Photo: Business Wire)
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 percent of people who have an AFib-related stroke find out they have AFib only after a stroke has occurred.4
“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 co-founder and CTO. “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 the submission process to regulatory agencies, Fitbit conducted a multi-site clinical trial in regions across the U.S. The study evaluated our algorithm’s ability to accurately detect AFib from normal sinus rhythm and to generate an ECG trace, or recording of a heart’s electrical rhythm, that is qualitatively similar to a Lead I ECG. The study showed that the algorithm exceeded target performance, demonstrating the ability to detect 98.7% of AFib cases (sensitivity) and was 100% accurate in identifying study participants with normal sinus rhythm (specificity).