The Food and Drug Administration has granted De Novo classification to a sleep apnea feature developed by Samsung for use via the Health Monitor app, according to a company press release.
The sleep apnea feature will be available on watches in Samsung’s Galaxy series in the third quarter of 2024, according to the press release.
The sleep apnea feature allows individuals older than 22 years to track their sleep twice for more than 4 hours within a 10-day period. The feature identifies breathing disruptions.
The feature “is expected to help more people proactively detect moderate or severe forms of OSA and, as a result of the detection, seek medical care to reduce the possibility of health-related complications,” according to the company.
Health-related complications associated with poor sleep include increased risk for hypertension, coronary artery disease, heart failure, and stroke, as well as fatigue, decreased mental and emotional well-being, and problems in personal relationships, according to the release.
The feature is not meant for use by individuals with a sleep apnea diagnosis, nor should it replace traditional sleep apnea assessment and diagnosis by qualified clinicians, the company noted.
The feature on the app was approved by Korea’s Ministry of Food and Drug Safety in October 2023.
A version of this article appeared on Medscape.com.