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Samsung: FDA Authorization of Galaxy Watch Feature Will Drive Sleep Apnea Detection, Care
New feature will be available in the United States later this year.

February 16, 2024 by Tim Mullaney

More people might soon be seeking treatment for sleep apnea – and acquiring needed home medical equipment – due to a new feature available on the Samsung Health Monitor app.

The U.S. Food and Drug Administration (FDA) has granted De Novo authorization for the sleep apnea feature on the Health Monitor app, Samsung announced on Feb. 10.

The app can be used on a compatible Samsung Galaxy Watch and phone. Users who are at least 22 years old and have not previously been diagnosed with sleep apnea can utilize the app over a two-night monitoring period to detect signs of moderate to severe obstructive sleep apnea (OSA), such as significant breathing disruptions.

“The new feature on the Samsung Health Monitor app 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,” Samsung stated in a press release.

The feature will be available in the United States in the third quarter of 2024, according to Samsung. The company also cautioned that the feature is not meant to replace diagnosis and treatment of sleep apnea by a “qualified clinician.”

About one-fifth of U.S. consumers who use a smartwatch or fitness tracker have a Samsung device, according to 2022-2023 data from Statista Consumer Insights.

And roughly 170 million people across North America and South America have sleep apnea, a 2019 ResMed study found.

“Previous estimates stated 100 million worldwide have sleep apnea,” Carlos M. Nunez, M.D., co-author of the study and ResMed Chief Medical Officer, noted at the time of the study’s release. “Now we know it’s nearly double that in just the Americas alone.”

The availability of the Samsung app conceivably could help raise awareness of sleep apnea, given that many people misunderstand the condition, according to a consumer survey conducted in late 2020 by Itamar Medical, which makes technology and devices related to the care of sleep-disordered breathing.

However, there could be a barrier to overcome, in terms of how seriously users take the results of sleep monitoring via a smartwatch. While 33 percent of respondents to the Itamar survey said they had used a wearable device or app to track or monitor their sleep, only 41 percent of those people said they took the results seriously enough to seek medical evaluation or treatment.

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