Google’s Fitbit is the latest company to receive FDA clearance for a wearable to detect atrial fibrillation. Fitbit submitted its photoplethysmography algorithm to identify AFib for review last month.
The algorithm’s validation was supported by data from the Fitbit Heart Study, which was launched in May of 2020 and enrolled 455,699 participants over five months. The study was significant because it was one of the largest virtual studies of PPG-based software to date.
Data presented at the 2021 American Heart Association Scientific Sessions found that the Fitbit PPG detections correctly identified AFib episodes 98% of the time, as confirmed by ECG patch monitors.
The company follows in the footsteps of Apple, which won a nod from FDA for irregular heartbeat detection in 2018. The clearance moved the needle – not in terms of innovation, but more so in terms of awareness. Apple’s clearance put a huge spotlight on atrial fibrillation.