Fitbit Receives Regulatory Clearance in Both the United States and Europe for ECG App to Identify Atrial Fibrillation (AFib)
FITBIT INC (FIT)
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Source: Business Wire
With FDA 510(k) clearance and CE mark, the Fitbit ECG App may help prevent serious complications like stroke by allowing users to spot check for signs of AFib from their wrist SAN FRANCISCO--(BUSINESS WIRE)--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.2,3This press release features multimedia. View the full release here: https://www.businesswire.com/
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