Wired
Gadgets & Wearables has reported that the Fitbit app’s “Irregular Heartbeat Notification” has acquired the CE mark (the mark of conformity with EU member states) and has started to be offered in Europe.
Launched in Europe following the United States-Not available in Japan
The Fitbit app’s “irregular heartbeat notification” has already been approved by the US Food and Drug Administration (FDA), but now that it has received the CE mark, it will also be available in Europe. .
Gadgets & Wearables said that the application for the CE mark acquisition of the Fitbit application was made in March 2022.
Gadgets & Wearables explains that it took about five months to get the app’s CE mark, which was a little longer than the time it took from FDA application to approval.
The time from application to FDA approval was less than a month.
Announced detection rate higher than Apple Watch
The “irregular heart rate notification” function in the Fitbit app detects atrial fibrillation by photoplethysmography (PPG) using a sensor installed in a Fitbit smartwatch that can measure electrocardiograms. is.
In a study conducted by Fitbit in the United States in 2020, it was reported that the Fitbit smartwatch had a 98% detection rate for atrial fibrillation, compared to 84% for the Apple Watch.
Source: Gadgets & Wearables
(FT729)
Source: iPhone Mania