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Samsung Receives FDA Approval for Smartwatch Sleep Apnea Tracker

Samsung is introducing the first FDA-approved sleep apnea feature1 for their Galaxy watch. This feature, known as the Samsung Health Monitor app, will be available during the summer of 2024. 

According to Samsung, this will allow those aged 22 and older who haven’t been formally diagnosed with obstructive sleep apnea (OSA) to receive data on their sleep habits to potentially detect moderate to severe OSA symptoms. For the most accurate results, users are advised to wear their watch for at least four hours while they sleep, and this should be done twice within 10 days.1

Samsung’s sleep apnea feature was previously approved by Korea’s Ministry of Food and Drug Safety2 in the Fall of 2023. 

OSA is one of the most underdiagnosed sleep disorders3, and researchers believe that as many as a billion adults may have mild to severe OSA. They also stress the importance of diagnosis and treatment since OSA can lead to serious health risks like high blood pressure, cancer, and cardiovascular diseases — among others. 

Often, people with OSA don’t even realize they present certain symptoms, which can include periodic pauses in breathing, slow or shallow breathing, loud snoring, and excessive daytime sleepiness.

Learn more: Signs of Sleep Apnea

This is where a feature like the Samsung Health Monitor App could help. 

As you sleep, the watch’s BioActive Sensor tracks your blood oxygen levels, with drops being a sign of sleep apnea due to slow or unsteady breathing. The app will estimate an apnea-hypopnea index (AHI) based on how often blood oxygen levels drop because of blocked breathing.

The AHI4 is a measurement to determine how many apneas or hypopneas you experience every hour during sleep. Apnea is the formal name for breathing pauses, while hypopnea is the formal name for slow or shallow breathing.2

Samsung’s sleep apnea tracker should help detect these warning signs, encouraging more people to seek an official sleep apnea diagnosis. If you suspect you have sleep apnea, you should make an appointment with a healthcare provider or sleep specialist. 

Sosha Lewis

Sosha Lewis

Content Writer

About Author

Sosha Lewis is a staff writer for Sleep Advisor.  Lewis is happy that she is able to combine her love of sleep with her love of writing.

Combination Sleeper


  1. “Samsung’s Sleep Apnea Feature on Galaxy Watch First of Its Kind Authorized by US FDA”. Samsung Newsroom. 2024.
  2. “Samsung Brings Sleep Apnea Feature to Galaxy Watch Upon Approval by Korea’s Ministry of Food and Drug Safety”. Samsung Newsroom. 2023.
  3. “Time to wake the giant of obstructive sleep apnoea”. The Lancet Respiratory Medicine. 2020.
  4. “Understanding the Results”. Harvard Medical School. Last modified April 16, 2021.