Fitbit receives FDA clearance for algorithm to detect AF
Click Here to Manage Email Alerts
The FDA has cleared Fitbit’s photoplethysmography-based algorithm to detect atrial fibrillation in wearers of its devices, the company announced.
The clearance was based on the results of the Fitbit Heart Study, the company stated in a press release.
As Healio previously reported, in the Fitbit Heart Study of 455,669 participants who were at least 22 years old, had a compatible Fitbit device (Ionic, Charge 3, Charge 4, Inspire HR or Inspire 2 trackers or Versa, Versa Lite, Versa 2, Versa 3 or Sense smartwatch), had an Android or iOS smartphone with the Fitbit app, and had no prior diagnosis of AF or atrial flutter, use of oral anticoagulation or implantation of a pacemaker or defibrillator, the positive predictive value of the algorithm for concurrent AF on the ECG patch monitor was 98.2%.
According to the release, the photoplethysmography-based algorithm enables long-term assessment that could enable identification of asymptomatic AF, while a spot-check approach with the company’s ECG app allows consumers to screen themselves for AF and share ECG traces with health care providers.
In a presentation at the American Heart Association Scientific Sessions in November, Steven Lubitz, MD, MPH, associate professor of medicine at Harvard Medical School and cardiac electrophysiologist at Massachusetts General Hospital, said the algorithm while the wearer is inactive continuously samples pulse data in 5-minute tachograms overlap by 50%, and flags an irregular heart rhythm if 11 consecutive tachograms are irregular.
In the Fitbit Heart Study, 1% of participants had an irregular heart rhythm detection, and 32.2% of participants with an irregular heart rhythm detection who submitted ECG readings had confirmed AF. Those with confirmed AF had a median AF burden of 7%.
Perspective
Back to Top
Jonathan P. Piccini, MD, MHS, FACC, FAHA, FHRS
It is great to see new screening technologies get approved for the potential detection of AF. The results of the Fitbit Heart Study were encouraging, with detection having a positive predictive value of 98%. The algorithm is user-friendly and can operate in the background during normal activity.
The approval will expand the currently available technologies for AF screening. The availability of the algorithm will incorporate AF screening into yet another household wearable device. However, it is a pulse-based PPG technology, and like all PPG technologies, any potential screen finding requires confirmation and validation with an electrocardiographic heart rhythm monitoring technology.
A lot of attention (and controversy) has been focused on screening recommendations using electrocardiograms in clinics and dedicated public health efforts. However, as AF screening technologies are embedded in more and more consumer devices, the need for dedicated clinic-based first-pass screening may become less important.
Collapse
Read more about
Click Here to Manage Email Alerts