Approval from Korea’s Ministry of Food and Drug Safety Enables Samsung to Introduce Sleep Apnea Feature in Galaxy Watch

New feature joins Samsung Health Monitor app to enable more people to discover sleep apnea in early stages

Samsung Electronics today announced that the new sleep apnea feature¹ on the Samsung Health Monitor app² has been approved by Korea’s Ministry of Food and Drug Safety (MFDS), and will be coming to Galaxy Watch series in Korea early next year. The new feature is expected to enable more people to spot obstructive sleep apnea symptoms in early stages which often goes undiagnosed and untreated.

“Samsung remains committed to delivering advanced technologies to Galaxy wearables that help more people better understand and take control of their wellness,” said Hon Pak, Vice President and Head of Digital Health Team, MX Business at Samsung Electronics. “With the new sleep apnea feature on Galaxy Watch series, we are providing users with a simple, proactive tool to recognize this disorder in its earliest possible stages before their condition worsens.”

Considered a common yet serious medical condition, sleep apnea causes someone to stop breathing while asleep, which can result in disruptions in oxygen supply, lower sleep quality, and other health complications such as hypertension, cardiac disorder, stroke or cognitive disorder. According to the National Sleep Foundation, roughly 25 percent of men and 10 percent of women in the US suffer from obstructive sleep apnea,³ of which many fail to recognize their symptoms or seek medical treatment. The new sleep apnea feature is designed to enable more people to proactively spot symptoms of the condition, encourage discovering earlier, and further reduce the possibility of health related complications.

By leveraging Galaxy Watch’s BioActive Sensor, the sleep apnea feature monitors blood oxygen levels during sleep and identifies moderate to severe obstructive sleep apnea by analyzing how the detected blood oxygen values change to apnea/hypopnea, then estimates Apnea-Hypopnea Index (AHI). Users are simply required to track their sleep twice, each time more than 4 hours, within 10 days to gauge whether they have these symptoms.

Galaxy Watch’s new sleep apnea feature joins blood pressure monitoring,⁴ electrocardiogram (ECG) detection⁵ and irregular heart rhythm notification (IHRN)⁶ as the latest addition to the Samsung Health Monitor app, giving users a better understanding of their holistic health — all right from their wrist. It will be made available on Galaxy Watch series in Korea via Samsung Health Monitor app updates beginning early next year.⁷

¹ The sleep apnea feature is only a pre-diagnosis tool. It isn’t meant to replace diagnosis or treatment by a qualified healthcare professional. If you aren’t feeling well, contact your doctor, even if the watch doesn’t detect sleep apnea. DON’T use this feature if you’ve already been diagnosed with sleep apnea. Your Galaxy Watch can’t catch every case of obstructive sleep apnea. The watch only checks for possible moderate to severe obstructive sleep apnea and can’t detect central sleep apnea.
² Availability may vary by market or device. Due to market restrictions in obtaining approval/registration as a Software as a Medical Device (SaMD), it only works on watches and smartphones purchased in the markets where service is currently available (however, service may be restricted when users travel to non-service markets). This app can only be used for measuring in ages 22 and over.
³ National Sleep Foundation: https://www.thensf.org/do-i-have-obstructive-sleep-apnea/
⁴ The Blood Pressure feature is only available in select markets. To ensure accuracy, users should calibrate their device every four weeks with a traditional blood pressure cuff. The BP feature cannot diagnose hypertension, other conditions, or check for signs of a heart attack. It is not meant to replace traditional methods of diagnosis or treatment by a qualified healthcare professional.
⁵ The ECG feature is only available in select markets. It is not intended to replace traditional methods of diagnosis or treatment. The feature is not intended for users with known arrhythmias other than AFib. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
⁶ The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present. It is not intended for users with other known arrhythmias.
⁷ Availability may vary by market, carrier, model, or a paired smartphone. It will be available on Galaxy Watch6 and Watch5 series.