Tuesday, April 16, 2024

Samsung Surpasses Apple with Sleep Apnea Detection in FDA-Approved Galaxy Watch

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Samsung Electronics has achieved a significant milestone in the health technology sector by obtaining de novo authorization from the Food and Drug Administration (FDA) for its innovative smartwatch and accompanying mobile application designed to detect signs of sleep apnea. This authorization positions the Samsung Galaxy Watch as a groundbreaking device capable of identifying moderate to severe obstructive sleep apnea (OSA) in individuals aged 22 and older, setting a new standard in wearable health technology.

The FDA’s approval of the Samsung Galaxy Watch for sleep apnea detection provides Samsung with a competitive edge over Apple, which had also been exploring the addition of a sleep apnea feature to its smartwatch, as reported by Bloomberg. This development marks a pivotal moment in the wearable technology market, offering users of Google’s Android operating system a viable alternative to the Apple Watch, which has traditionally boasted a wider array of health features.

Samsung Galaxy Watch Advances Beyond Apple with FDA-Approved Sleep Apnea Detection Feature

Until now, Apple Watch users enjoyed exclusive access to health functionalities like irregular heart rhythm notifications—a feature that Samsung only incorporated into its device last year after receiving 510(k) clearance. However, with this latest FDA authorization, Samsung not only catches up but also surpasses its competitor by introducing a much-anticipated health monitoring capability ahead of Apple’s planned update.

The FDA’s decision came after an eight-month review process, culminating in the authorization on February 6. This comes on the heels of the feature’s approval in Korea four months prior. The Samsung Galaxy Watch’s sleep apnea detection feature operates over a two-night monitoring period to identify significant breathing disruptions, enabling “on-demand use” for individuals not previously diagnosed with sleep apnea. It’s important to note that this device is not intended to replace traditional diagnostic methods or assist clinicians in diagnosing OSA.

Sleep Apnea

A New Era for Detecting Sleep Apnea and Shaping Public Health

The introduction of consumer devices capable of detecting signs of sleep apnea could significantly impact public health by facilitating earlier diagnosis of the condition. According to a 2019 paper funded by Resmed and highlighted by The Lancet Respiratory Medicine, nearly 1 billion people worldwide suffer from OSA, a condition that remains largely underdiagnosed and unrecognized.

The de novo authorization of the Samsung Galaxy Watch feature categorizes it as a class II product, under the generic name “over-the-counter device to assess risk of sleep apnea.” This regulatory milestone opens the door for other companies to enter the market with similar devices by demonstrating substantial equivalence to Samsung’s offering and adhering to the special controls established through the de novo process.


Resource: Medtechdive, February 14, 2024

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