Fitbit’s Sense smartwatch gets FDA clearance for EKG app - Only three watches have the clearance in US: Apple, Fitbit Sense and Samsung Galaxy Watch 3

The heart-monitoring electrocardiogram (EKG) app on Fitbit’s new Sense smartwatch has been cleared by the US Food and Drug Administration (FDA). The feature can track heart rhythms and look for signs of atrial fibrillation, the most common type of irregular heartbeat.

Atrial fibrillation puts people at increased risk for stroke and other heart conditions. Wearable devices can monitor people continuously throughout the day and may be able to flag a problem a traditional heart monitor (which only measures heart rate at specific time points) might miss.

Fitbit ran a small study of its software last year, which found that it could accurately detect 98.7 percent of atrial fibrillation cases.

Withings has two smartwatches with EKG features, but it doesn’t have FDA clearance, so neither can be sold in the US. (They’re available in Europe.)

See Fitbit’s Sense smartwatch gets FDA clearance for EKG app

#technology #health #smartwatch #wearables


Just in time for the product’s launch.