Fitbit has earned regulatory clearance in the U.S. and the EU for an electrocardiogram (ECG) app that detects atrial fibrillation, or AFib – an irregularity of the heartbeat that can increase the risk of a stroke. Specifically, the device has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and the CE (Conformité Européenne) marking for medical devices trading in the European Economic Area (EEA). The app is one of the products Fitbit is introducing this autumn and will be available through the Fitbit Sense smartwatch as of October in the U.S., the U.K., Germany, Austria, Luxembourg, the Netherlands, Sweden, Switzerland, the Czech Republic, Poland, Belgium, Portugal, Romania, Ireland, Italy, Spain, France, Hong Kong and India.