Samsung Electronics Co., Ltd. has announced a groundbreaking achievement: the US Food and Drug Administration (FDA) has granted De Novo authorization to the sleep apnea feature on the Samsung Health Monitor app. This marks the first time such a feature has received FDA approval, following its initial authorization by South Korea’s Ministry of Food and Drug Safety last October.
The sleep apnea feature, compatible with select Samsung Galaxy Watches and Phones, enables users aged 22 and above to identify signs of moderate to severe obstructive sleep apnea (OSA) over a two-night monitoring period. OSA, a prevalent yet often undiagnosed sleep disorder, can lead to breathing interruptions during sleep, resulting in decreased oxygen levels, poor sleep quality, and daytime fatigue.
By simply tracking their sleep twice for over four hours within a ten-day span, users can leverage this feature to detect potential OSA issues. Left untreated, OSA can escalate the risk of various cardiovascular diseases, including hypertension, coronary artery disease, and stroke. Studies indicate that around 25% of men and 10% of women in the US experience OSA, underscoring the significance of early detection and intervention.
Recognizing the integral role of sleep in overall health, Samsung is dedicated to enhancing sleep quality through understanding sleep patterns, fostering healthier habits, and creating conducive sleeping environments. With the introduction of the sleep apnea feature, Samsung continues its commitment to providing Galaxy users with comprehensive tools to optimize their sleep health.
The feature is set to roll out on the Galaxy Watch series in the US via the Samsung Health Monitor app in the third quarter, promising to empower users to proactively manage their sleep health and improve their overall well-being.
