Samsung Receives FDA Approval for Sleep Apnea Detection Feature on Galaxy Watches



Samsung Electronics has garnered approval from the U.S. Food and Drug Administration (FDA) to introduce a novel sleep apnea detection feature for its Galaxy Watch users in the United States. This development marks Samsung as the pioneer smartwatch maker to secure such regulatory clearance from the FDA. Notably, the company had previously attained approval for this feature in South Korea in October 2023.

Sleep apnea, a chronic condition impeding breathing during sleep, poses significant health risks including compromised sleep quality and heightened susceptibility to severe ailments such as heart disease. Despite its prevalence, sleep apnea often goes undiagnosed.

While Samsung has not divulged specifics regarding the methodology underlying the detection feature, the Galaxy Watch comes equipped with sensors requisite for monitoring factors associated with sleep apnea. Notably, the watch is adept at accurately tracking variations in blood oxygen levels and heart rate, crucial metrics for the functionality of the feature.

To leverage the feature, users are required to wear the watch during sleep for a minimum of two nights within a ten-day span to amass adequate data for analysis. Subsequently, users can access the results via the Samsung Health Monitor app. It's important to underscore that the feature caters exclusively to adults aged 22 and above who have not previously received a diagnosis of sleep apnea.

The integration of sleep apnea detection bolsters the Galaxy Watch's array of health monitoring capabilities. While not intended to replace formal diagnosis, the feature holds potential for proactive detection of sleep apnea, potentially offering life-saving benefits.

In parallel, reports suggest that Apple Inc. is also in the process of developing a sleep apnea detection feature for its smartwatch. However, the company may encounter challenges due to ongoing legal constraints surrounding its SpO2 sensor.

The sleep apnea detection feature is slated for rollout to Galaxy Watch users in the United States later this year. However, it is anticipated to be accessible solely on newer models such as the Galaxy Watch 5 and 6 series.

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