Withings’ ScanWatch with EKG and Blood Oxygen Sensor has been approved by the FDA.
(Picture courtesy of Pixabay/PhotoMIX-Company) EKG from a smartwatch After more than a year of attempting to convince the FDA to approve Withings’ ScanWatch, the agency has finally done so.
The built-in EKG feature on the Withings ScanWatch monitors the user’s irregular cardiac rhythms, and its blood oxygen sensor alerts overnight breathing issues.
Although the smartwatch has been accessible in Europe for several months, it is yet to be released in the United States.
ScanWatch has been approved by the FDA.
According to The Verge, the ScanWatch is the first wristwatch to be authorized by the Food and Drug Administration for containing both an EKG and a blood oxygen sensor.
Fitbit, Samsung smartwatches, and Apple Watch all detect blood oxygen levels, but they don’t promise to be able to detect the user’s medical issues using that data, so they didn’t need FDA approval to sell their products in the United States.
The ScanWatch, on the other hand, is claimed by Withings to be able to detect respiratory difficulties when the user is sleeping. The user’s heart rate, blood oxygen levels, and movement are all combined to acquire the data.
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Breathing issues, according to the business, can be a sign of sleep apnea or chronic obstructive pulmonary disease.
According to Withings, its health features have been put to the test in a number of clinical investigations.
Although the findings of one study on its EKG function were not released, the business claimed that the feature was accurate and only provided inconclusive readings one-fifth of the time.
Meanwhile, the Journal of Medical Internet Research published its research on the pulse oxygen feature. It was discovered that the data from the smartwatch matched that of a pulse oximeter.
Between the ages of 23 and 39, 14 people with various skin tones took part in the study. During the trial, none of the subjects had any medical difficulties.
The company is also conducting research to see if the ScanWatch can accurately identify sleep apnea in users.
Other smartwatch manufacturers are also working on sleep apnea capabilities for their products. For years, Fitbit has been working on the same feature.
Fitbit plans to seek for FDA certification shortly, according to Gizmodo, although no precise date has been given. Apple is also rumored to be working on sleep and blood oxygen features for the Apple Watch. News from Brinkwire in a nutshell.