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Samsung wins Korean clearance to grade sleep apnea by the hour

South Korea's MFDS approved Samsung's upgraded sleep apnea algorithm, which sorts breathing disruptions into three frequency levels rather than a yes-or-no result.

MedSpark Staff
By
msadmin
MedSpark Staff
Bymsadmin
Medical, Healthcare, & Biotech/Pharma AI News
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Published: October 28, 2026
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Samsung’s sleep apnea feature has told users whether signs were present. A new version approved in Korea tells them how often it happens, hour by hour, across a night.

Contents
Which devices get it, and whenA screening label the company keeps repeating

South Korea’s Ministry of Food and Drug Safety cleared the upgraded algorithm on October 28. It analyzes the frequency of hourly breathing disturbances and sorts results into three levels labeled mild, occasional and frequent, replacing the earlier binary check.

Which devices get it, and when

In Korea the feature reaches Galaxy Watch 9, Galaxy Watch Ultra 2 and Galaxy Ring users from November 2026 through the Samsung Health Monitor app. Older hardware, including the Galaxy Watch 7 and Watch 8 series, will receive it later once those watches move to a stable One UI 9 Watch build on Wear OS 7.

The Wear OS 7.0 requirement leaves older owners behind; Galaxy Watch 4 and later models on Wear OS 5 keep the basic presence-or-absence check. To get a reading, a user needs at least five hours of recorded sleep twice within 10 days.

A screening label the company keeps repeating

US buyers have had this version since July, when the FDA cleared it and Samsung shipped it on the Watch 9 and Watch Ultra 2. Samsung describes the tool as an over-the-counter aid for assessing risk in adults 18 and over who have not been diagnosed with sleep apnea.

It flags signs of moderate-to-severe apnea so users know to see a clinician. It does not diagnose anything, a distinction that matters as consumer wearables push further into regulated territory.

The feature first won Korean approval as software as a medical device in 2023, followed by FDA De Novo authorization in February 2024 and Brazilian approval in 2025. Samsung says it is now offered in 84 countries.

TAGGED:Digital HealthGalaxy RingMFDSSaMD regulationSamsungsleep apnea
SOURCES:Sammy FansAndroidPure
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Medical, Healthcare, & Biotech/Pharma AI News

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