14 DAY TRIAL // Fitbit has just announced that its ECG feature has recently received regulatory clearance in the United States and Europe.
Fitbit Sense, the company’s latest smartwatch is projected to launch in just a few days, and it will come with a dedicated ECG app pre-loaded. However, this feature won’t be available on day one, as Fitbit was waiting for regulatory approval, and the company plans to enable it at a later time with a software update.
The company today confirmed that it received clearance in both the United States and Europe.
The following countries will get support for ECG in October: 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.
How to conduct an ECG reading
Fitbit says it also conducted a clinical trial in the U.S. that is supposed to help the company improve ECG readings on its devices.
“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),” the company explained.
In order to use the ECG feature, users need to launch the dedicated app on the smartwatch and then hold their fingers on the stainless steel ring on the device for 30 seconds. The readings can then be downloaded and shared with a doctor, Fitbit explains.