Today Google received FDA clearance for Fitbit’s algorithm that detects atrial fibrillation. A short distance from the submission of the application for approval, there is now the green light, which allows the Mountain View giant to market in the United States Fitbit-branded smartwatches and wearables even more as medical devices.
Google Receives FDA Yes for Fitbit’s AFIB Feature
Fitbit’s AFIB technology allows you to detect if the wearer has irregular beats (simplifying). Atrial fibrillation is a very common pathology (about 33.5 million people in the world suffer from it), a pathology that consists of an alteration of the heart rhythm, which is very rapid and, in fact, irregular.
This results in problems in the contraction of the atrial cavities that consequently affect the functionality of the ventricles and the blood flow itself. Among other things, for those suffering from atrial fibrillation the level of risk of heart attack is 5 times higher than normal.
Fitbit devices periodically check the wearer’s heartbeat through this dedicated feature, which sends alerts if they detect signs of atrial fibrillation. Unlike the previous function, available through a dedicated ECG app and approved by the FDA, this new option is not based on manual checks (ie initiated by the user himself), but performs random checks automatically, working in the background (while we sleep or not) and, for this reason, it is much more interesting and useful.
How does that work? The AFIB PPG sensor (a sphygmomanometer technology that detects and controls the incidence of atrial fibrillation) allows Fitbits to detect changes in blood volume, changes that determine heart rhythm and are analyzed by a dedicated algorithm that allows to detect irregularities and estimate potential signs of atrial fibrillation.
The clinical validation comes from a study that took its first steps 2 years ago taking into account over 450 thousand people over 5 months. The resulting data was then presented in 2021 at the America Heart Association Scientific Sessions from which it emerged that Fitbit’s PPG sensor and the related algorithm correctly detected 98% of cases.
And hence today’s FDA approval of this new tool allows Fitbit to provide users with an extra option, which can be useful to help people thereby reducing the risks of latent atrial fibrillation problems.
At the moment Google says that this new feature will be available soon for US users. But to learn more, we invite you to read the related Google press release.