FDA clears Withings’ EKG and blood oxygen features
After over a year in limbo, Withings finally has Food and Drug Administration clearance for its ScanWatch, which monitors for abnormal heart rhythms through an EKG feature and flags nighttime breathing issues with its blood oxygen sensor. The watch has been available for sale in Europe, but not in the United States.
This is the first smartwatch to get the FDA’s signoff on both types of health features. Apple, Fitbit, and Samsung all detect blood oxygen levels, but they don’t claim they can detect any medical conditions using that information, so they didn’t need to get the agency’s clearance in order to market the devices. Withings, on the other hand, is claiming that its device can flag nighttime breathing problems through a…