Fitbit Cleared for , Passive Heart Rhythm Monitoring by FDA.
Fitbit Cleared for , Passive Heart Rhythm Monitoring by FDA.
The company made
the announcement on April 11.
Today, Fitbit received clearance from the U.S. Food and Drug Administration for our new PPG (photoplethysmography) algorithm to identify atrial fibrillation (AFib), Fitbit, via blog post.
According to the Mayo Clinic, AFib "is an irregular and often very rapid heart rhythm (arrhythmia) that can lead to blood clots in the heart." .
The condition increases the risk of heart-related issues such as heart failure and stroke.
According to a 2010 study, AFib affects
about 33.5 million people worldwide.
Our new PPG AFib algorithm can passively assess your heart rhythm in the background while you’re still or asleep. , Fitbit, via blog post.
If there’s anything that might be suggestive of AFib, you’ll be notified through our Irregular Heart Rhythm Notifications feature — allowing you to talk with your healthcare provider or seek further assessment to help prevent a significant medical event, such as stroke, Fitbit, via blog post.
Fitbit previously had an EKG app that was cleared by the FDA to check for signs of AFib, but it required users to manually take readings.
The new feature runs automatically in the background. It will be available in the U.S. "soon."