FDA Approves EKG and Blood Oxygen Features of Withings

After more than a year, Withings has finally received Food and Drug Administration approval for its ScanWatch, which monitors abnormal heart rhythms through an EKG feature and with its own blood oxygen sensor. Marks shortness of breath during the night. The watch is available for sale in Europe, but not in the United States.

This is the first smartwatch to get FDA signoff on both types of healthcare facilities. Apple, Fitbit, and Samsung all detect blood oxygen levels, but they don't claim they can use that information to diagnose any medical condition, so they've got agency approval for marketing the devices. Have to take was not required. On the other hand, Withings is claiming that its device can flag breathing problems at night through a combination of blood oxygen levels, heart rate and speed. The company said in a statement that shortness of breath could be a sign of chronic obstructive pulmonary disease and sleep apnea.

Withings says its health characteristics have been tested in clinical studies. One tested the EKG feature – the results of that study have not been published, but the company said it showed the feature was accurate and returned inconclusive readings one-fifth of the time. Its evaluation of the pulse oxygen feature, published in the Journal of Medical Internet Research, found that ScanWatch's readings matched readings from a standard pulse oximeter. The study included 14 people with a variety of skin tones between the ages of 23 and 39 who had no medical problems.

The company is also running a trial to see if ScanWatch can diagnose sleep apnea.

Other smartwatch companies are also working on a sleep apnea feature. Fitbit has been working on a similar feature for years and told Gizmodo in early 2020 that it was planning to file for FDA approval "soon." Apple is also reportedly working on the Apple Watch's sleep and blood oxygen features with the goal of detecting sleep apnea.

Sleep experts say they're excited about smartwatches' potential to help detect conditions like sleep apnea, which often goes undiagnosed. But the watches only track certain measurements that doctors typically use to diagnose the condition, and for now, experts say they aren't reliable enough to stand alone. Seema Khosla, medical director of the North Dakota Center for Sleep, told The Verge that they are more useful as early screeners.

Withings says ScanWatch will be available in the US in early November.