Samsung Galaxy Watch Gets FDA Approval To Detect Sleep Apnea

The company said that the sleep apnea function within the Samsung Health Monitor app has obtained De Novo authorisation from the US FDA.

Sleep apnea is a medical condition characterised by brief interruptions in proper breathing during sleep.

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Samsung has just received approval from the US Food and Drug Administration (FDA) to use the Galaxy Watch for detecting sleep apnea in wearers, the company has announced. The company said that the sleep apnea function within the Samsung Health Monitor app has obtained De Novo authorisation from the US FDA. This feature, capable of detecting sleep apnea using a compatible Samsung Galaxy Watch model and smartphone, marks the first of its kind to receive FDA approval, subsequent to its prior approval by Korea’s Ministry of Food and Drug Safety (MFDS) announced last October.

"The sleep apnea feature enables users over the age of 22 who have not been diagnosed with sleep apnea to detect signs of moderate to severe obstructive sleep apnea (OSA) over a two-night monitoring period, a common and chronic sleep condition that often goes undiagnosed and untreated. To use the feature, users can simply track their sleep twice for more than four hours within a ten-day period," the company wrote in a post.

What Is Sleep Apnea

Sleep apnea is a medical condition characterised by brief interruptions in proper breathing during sleep. It includes various forms, including "Central Sleep Apnea," in which the brain fails to send adequate signals to control breathing during sleep, and "Obstructive Sleep Apnea," where relaxed muscles obstruct the airflow into the lungs.

OSA causes a person to stop breathing while sleeping and can often result in disruptions in oxygen supply, decreased sleep quality and increased daytime fatigue. Untreated sleep apnea can compound the risk of cardiovascular diseases such as hypertension, coronary artery disease, heart failure, cardiac arrhythmia and stroke.

According to the National Sleep Foundation (NSF), roughly 25 per cent of men and 10 per cent of women in the US experience OSA, the company noted in the post.

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.