News DeskSEOUL, Korea – Samsung Electronics Co., Ltd. has announced that its sleep apnea feature on the Samsung Health Monitor app has received De Novo authorization from the United States Food and Drug Administration (FDA). This innovative feature, compatible with Samsung Galaxy Watch and Phone, detects signs of sleep apnea, marking a significant milestone as the first of its kind to be authorized by the FDA. Previously approved by South Korea’s Ministry of Food and Drug Safety (MFDS) in October, the feature is aimed at aiding users over the age of 22 in detecting moderate to severe obstructive sleep apnea (OSA) over a two-night monitoring period.
OSA is a prevalent and chronic sleep condition that often goes undiagnosed, leading to disruptions in oxygen supply, lower sleep quality, and daytime fatigue. Left untreated, it can significantly increase the risk of cardiovascular diseases. With roughly 25% of men and 10% of women in the U.S. experiencing OSA according to the National Sleep Foundation (NSF), the new feature on the Samsung Health Monitor app is expected to help individuals proactively detect OSA and seek appropriate medical care, potentially reducing health-related complications.
Recognizing the vital role of sleep in overall health and well-being, Samsung emphasizes understanding sleep patterns, building better habits, and creating a sleep-friendly environment. The introduction of the sleep apnea feature further solidifies Samsung’s commitment to providing Galaxy users with tools to improve their sleep health habits. The feature is set to be available on the Galaxy Watch series in the US via the Samsung Health Monitor app in the third quarter.
