The FDA has finally given its seal of approval to Withings after trying to get its ScanWatch cleared for more than a year.
The Withings' ScanWatch monitors the user's abnormal heart rhythms through its built-in EKG feature, and it also flags nighttime breathing problems with its blood oxygen sensor.
The smartwatch has been available in Europe for months, but it is not yet sold in the United States.
FDA Approves ScanWatch
The ScanWatch is the first-ever smartwatch approved by the Food and Drug Administration for having both the EKG and blood oxygen sensor features, according to The Verge.
Fitbit, Samsung smartwatch, and Apple Watch all detect blood oxygen levels, but they do not claim that they can detect the user's medical conditions using that data, so they did not need to get clearance from the FDA in order to sell their devices in the country.
On the other hand, Withings is claiming that the ScanWatch can detect breathing issues while the user is sleeping. The data is collected by combining the user's heart rate, blood oxygen levels, and movement.
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According to the company, the breathing problems can be a sign of sleep apnea and chronic obstructive pulmonary disease.
Withings stated that its health features had been tested in several clinical studies.
One study tested its EKG feature, and although the results from that study were not published, the company claims that it showed the feature was accurate and returned inconclusive readings one-fifth of the time.
Meanwhile, its study of the pulse oxygen feature was published in the Journal of Medical Internet Research. It found that the data from the smartwatch matched up with the data produced by a pulse oximeter.
The study included 14 participants with different skin tones between the ages of 23 and 39. The participants did not have any medical issues during the study.
The company also has an ongoing trial testing to check if the ScanWatch can effectively diagnose sleep apnea in users.
Other smartwatch companies are currently pursuing sleep apnea features on their devices too. Fitbit has been working on the same feature for years.
According to Gizmodo, Fitbit is planning to file for FDA clearance soon but did not give a specific date. Apple is also said to be working on the Apple Watch's sleep and blood oxygen features, and it also wants its device to be able to detect sleep apnea.
Currently, Apple smartwatches are equipped with EKG, although the data is not proven to be accurate.
Medical experts stated that they are excited about the possibility of smartwatches detecting such medical conditions.
Sleep apnea usually goes undiagnosed and affects hundreds of people every year.
However, smartwatches only track some of the measurements that doctors normally use to diagnose the condition, according to Venture Beat.
For now, experts say that they are not reliable enough to stand alone, and they are better as an initial screener, according to Seema Khosla, a medical director of the North Dakota Center for Sleep.
Withings stated that the ScanWatch would be for sale in the US starting November.
Sleep Apnea
Sleep apnea is a sleeping disorder that leads to heart ailments, high blood pressure, and other serious health issues.
If left untreated, it can cause loud snoring, daytime tiredness, and breathing interruptions while sleeping.
The condition can affect everyone, but especially overweight men.
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Written by Sophie Webster
