Samsung Electronics has recently announced that its sleep apnea feature on the Samsung Health Monitor app has been granted De Novo authorization by the U.S. Food and Drug Administration (FDA). This groundbreaking feature, designed to identify sleep apnea indications using a compatible Samsung Galaxy Watch and phone, marks the first FDA-approved technology of its kind. Prior to this, it had already received approval from Korea’s Ministry of Food and Drug Safety (MFDS) in October. The sleep apnea feature is designed for users aged 22 and above who have not been diagnosed with sleep apnea. It facilitates the detection of signs of moderate to severe obstructive sleep apnea (OSA) over a two-night monitoring period, addressing a common and chronic sleep condition that often goes unnoticed. To access this feature, users can easily track their sleep twice for more than four hours within a ten-day period.
Obstructive sleep apnea leads to breathing interruptions during sleep, causing disruptions in oxygen supply, reduced sleep quality, and increased daytime fatigue. If left untreated, it can escalate the risk of cardiovascular diseases such as hypertension, coronary artery disease, heart failure, cardiac arrhythmia, and stroke. Statistics from the National Sleep Foundation (NSF) indicate that around 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 is expected to empower more individuals to proactively identify moderate or severe OSA, prompting them to seek medical attention and minimize potential health complications. Recognizing the crucial link between good health and quality sleep, Samsung is committed to promoting better sleep habits among its users.
The company acknowledges the pivotal role sleep plays in overall health and well-being, emphasizing three key elements: understanding sleep patterns, fostering better habits, and creating a sleep-friendly environment. With the integration of the sleep apnea feature, Samsung is advancing its dedication to providing Galaxy users with top-notch sleep tools to enhance their sleep health habits. The feature is slated to be available on the Galaxy Watch series in the U.S. through the Samsung Health Monitor app in the third quarter.