Sleep Apnea Smartwatch Feature Gets FDA Authorization

— Software is first of its kind to receive agency greenlight, set to roll out this year

by Elizabeth Short, Staff Writer, �鶹��ý February 12, 2024

A photo of a man wearing a Samsung Galaxy Watch

The FDA authorized an obstructive sleep apnea (OSA)-detecting feature on the Samsung Galaxy Watch, the company on Friday.

The feature is the first of its kind to receive the agency's de novo classification and is designed for use in wearers over the age of 22 years who have not been previously diagnosed with sleep apnea. Through the device's Health Monitor app, users can check sleep symptoms over a 2-night period. Wearers are required to track their sleep for a minimum of 4 hours at least twice within a 10-day period in order to utilize the OSA feature.

The feature monitors blood oxygen levels during sleep in order to identify possible moderate to severe OSA symptoms such as apnea or hypopnea. Using changes recorded in blood oxygen values, the app then estimates the wearer's Apnea-Hypopnea Index.

Apple recently announced that its Apple Watch Series 10 will carry a similar feature available for users when it releases later this year.

Sleep apnea affects an Americans. However, only 6 million people in the U.S. have actually been diagnosed with the condition. Samsung that the new feature is meant to help address this gap in diagnosis by enabling people to "proactively spot symptoms" and ultimately "reduce the possibility of health-related complications."

A lack of consistent sleep from disorders like OSA have been associated with a wide array of health issues ranging from cardiovascular issues (including an ) to cognitive issues to a higher risk for developing long COVID symptoms.

The Samsung Health Monitor app records data concerning blood oxygen percentage, snore detection and duration, sleep stages and cycling, sleep duration, sleep score, and overall sleep consistency through the watch's BioActive Sensor. Data are accessible through the watch and the associated smartphone app. The app also provides optional "sleep coaching" for interested users based on their personalized sleep data.

Samsung said it expects the OSA-detecting feature to become available via a software update in the third quarter of this year.

Elizabeth Short is a staff writer for �鶹��ý. She often covers pulmonology and allergy & immunology.