Samsung Galaxy Watch Sleep Apnea Feature Receives US FDA Authorization

Samsung Electronics Co., Ltd. announced that the sleep apnea functionality within the Samsung Health Monitor app has been granted De Novo authorization by the United States Food and Drug Administration (FDA).

This pioneering feature, which identifies signs of sleep apnea using compatible Samsung Galaxy Watches and Phones, marks the first of its kind to receive FDA approval, following its prior endorsement by South Korea’s Ministry of Food and Drug Safety (MFDS) last October.

The sleep apnea feature empowers users aged 22 and above, who have not yet received a sleep apnea diagnosis, to detect indications of moderate to severe obstructive sleep apnea (OSA) during a two-night monitoring period. OSA, a prevalent and chronic sleep disorder often undiagnosed and untreated, leads to breathing interruptions during sleep, disrupting oxygen supply, lowering sleep quality, and causing daytime fatigue. Untreated sleep apnea amplifies the risk of cardiovascular ailments like hypertension, coronary artery disease, heart failure, cardiac arrhythmias, and stroke. 

According to the National Sleep Foundation (NSF), approximately 25% of men and 10% of women in the U.S. experience OSA. The introduction of this new feature in the Samsung Health Monitor app aims to enable more individuals to proactively identify moderate to severe forms of OSA and seek medical assistance to mitigate potential health complications.

Recognizing the vital role of sleep in overall health and well-being, Samsung prioritizes three key elements for better sleep: understanding sleep patterns, cultivating healthier habits, and fostering a sleep-friendly environment. Good sleep is intricately linked to improved physical and mental health, enhanced relationships, and optimized performance in daily activities. Through its innovative approach, Samsung underscores the significance of quality sleep in promoting holistic wellness and vitality.