Fitbit receives regulatory clearance for atrial fibrillation detection in USA and EU
Fitbit has received regulatory clearance from the US Food and Drug Administration (FDA) and the EU for its electrocardiogram (ECG) app to assess heart rhythm for atrial fibrillation (AFib). AFib affects more than 33.5 million people across the globe. AFib increases the risk of serious complications, such as strokes which can be highly difficult to detect. The Fitbit ECG app will be available in October 2020 to Fitbit Sense users in the USA, the UK, Germany, Austria, Luxembourg, the Netherlands, Sweden, Switzerland, the Czech Republic, Poland, Belgium, Portugal, Romania, Ireland, Italy, Spain, France, Hong Kong, and India.