Samsung’s Groundbreaking Sleep Apnea Detection Feature on Galaxy Watch Receives First FDA Approval of Its Kind

By DaMarko Webster

Samsung Electronics has proudly announced that the sleep apnea feature within the Samsung Health Monitor app has secured De Novo authorization from the U.S. Food and Drug Administration (FDA). This pioneering feature, designed to identify indications of sleep apnea through compatible Samsung Galaxy Watches and phones, marks a significant milestone as the first of its kind to receive FDA authorization, following its previous approval by Korea’s Ministry of Food and Drug Safety (MFDS) in October, as announced in Korea.

This groundbreaking sleep apnea feature empowers users aged 22 and above, who have not been formally diagnosed with sleep apnea, to detect signs of moderate to severe obstructive sleep apnea (OSA) over a two-night monitoring period. OSA is a prevalent and chronic sleep disorder often undiagnosed and untreated, causing individuals to momentarily cease breathing during sleep, leading to disruptions in oxygen levels, diminished sleep quality, and increased daytime fatigue. Left untreated, sleep apnea can escalate the risk of cardiovascular ailments such as hypertension, coronary artery disease, heart failure, cardiac arrhythmia, and stroke. According to the National Sleep Foundation (NSF), approximately 25% of men and 10% of women in the U.S. grapple with OSA. The introduction of this new feature within the Samsung Health Monitor app is anticipated to aid more individuals in proactively identifying moderate to severe OSA and subsequently seeking medical assistance to mitigate potential health complications.

Recognizing the pivotal role sleep plays in overall health, Samsung underscores three fundamental pillars for enhancing sleep quality: understanding sleep patterns, cultivating healthier habits, and fostering a conducive sleep environment. As such, Samsung’s dedication to fostering improved sleep health among Galaxy users is exemplified through the introduction of the sleep apnea feature. Scheduled for availability on the Galaxy Watch series in the U.S. through the Samsung Health Monitor app in the third quarter, this feature represents a significant stride in Samsung’s ongoing commitment to providing users with premier sleep tools to bolster their well-being.