The Fitbit Sense’s ECG app launches next month in the U.S., Europe, and India
Wearables manufacturer Fitbit recently unveiled the Fitbit Sense, one of the most advanced smartwatches from the company. The new smartwatch packs in a variety of health and fitness tracking sensors, including an electrocardiogram (ECG) monitor, an electrodermal activity (EDA) sensor for managing stress, an on-wrist skin temperature sensor, and more. However, at the time of launch, the ECG feature on the smartwatch hadn’t received regulatory approval, and therefore the ECG app had not been released for users. Fitbit has now finally received regulatory approval for the ECG feature, and the company will soon start rolling out the ECG app to users.
As per a press release shared by the company, Fitbit has successfully received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and Conformité Européenne (CE) marking in the European Union for its ECG app. The ECG app will allow users to make use of the ECG monitor on the Fitbit Sense to assess their heart rhythm for arterial fibrillation (AFib). The Fitbit ECG app will be released for all Fitbit Sense users next month 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.
To receive proper certification for the app, Fitbit conducted a multi-site trial in regions across the U.S. The study evaluated the app’s ability to differentiate AFib from the normal sinus rhythm and to generate an ECG trace that is qualitatively similar to a Lead I ECG. The press release notes that Fitbit’s study “showed that the algorithm exceeded target performance, demonstrating the ability to detect 98.7% of AFit cases (sensitivity) and was 100% accurate in identifying study participants with normal sinus rhythm (specificity).”
Once the app rolls out next month, users will be able to hold their fingers on the stainless steel ring on the watch while being still for 30 seconds to get a reading. The app will also let users download and share the readings with doctors for a proper medical examination. It’s worth noting that Fitbit isn’t the only wearables manufacturer to have received regulatory approval for the ECG feature on its smartwatch. Samusung has also received similar certification for its Galaxy Watch Active 2 in South Korea and for the Galaxy Watch 3 in the U.S.