Samsung Electronics announced that the sleep apnea feature¹ on the Samsung Health Monitor app² has received De Novo authorization from the U.S. Food and Drug Administration (FDA). This feature, which detects signs of sleep apnea using a compatible Samsung Galaxy Watch and phone, was the first of its kind to be authorized by the FDA following previous approval by Korea’s Ministry of Food and Drug Safety (MFDS), announced last October in Korea.

The sleep apnea feature enables users over the age of 22 who have not been diagnosed with sleep apnea to detect signs of moderate to severe obstructive sleep apnea (OSA) over a two-night monitoring period, a common and chronic sleep condition that often goes undiagnosed and untreated. To utilize the feature, users can simply track their sleep twice for more than four hours within a ten-day period.

OSA causes a person to stop breathing while sleeping and can often result in disruptions in oxygen supply, decreased sleep quality and increased daytime fatigue. Untreated sleep apnea can compound the risk of cardiovascular diseases such as hypertension, coronary artery disease, heart failure, cardiac arrhythmia and stroke. According to the National Sleep Foundation (NSF), roughly 25% of men and 10% of women in the U.S. experience OSA. The new feature on the Samsung Health Monitor app is expected to help more people proactively detect moderate or severe forms of OSA, and as a result of the detection seek medical care to reduce the possibility of health-related complications.

Good health is strongly linked to good sleep. Sleep helps bodies and minds recover and empowers people to wake up refreshed and ready for the day ahead. The quality of sleep people get every night has a significant impact on their physical and mental well-being, relationships, performance and more. Samsung recognizes the foundational role that sleep serves in people’s health and well-being by focusing on three key elements for better sleep: understanding sleep patterns, building better habits and creating a sleep-friendly environment.

With the sleep apnea feature, Samsung is taking the next step in its ongoing commitment to provide Galaxy users with the best possible sleep tools to improve their sleep health habits. The feature will be available on the Galaxy Watch series in the U.S. via the Samsung Health Monitor app in the third quarter.³

¹ The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and phone. This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. It is intended for on-demand use. This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this device is also not intended to assist clinicians in diagnosing sleep disorders.
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 phones purchased in the markets where service is currently available (however, service may be restricted when users travel to non-service markets).
³ Availability may vary by market, carrier, model, or paired phone.

and track their blood pressure via the Samsung Health Monitor App

anytime, anywhere¹

Samsung Electronics announced today that the Samsung Health Monitor application has launched in South Korea, following its clearance by South Korea’s Ministry of Food and Drug Safety (MFDS) earlier this year. From today, Galaxy Watch Active2 users in Korea can access the Samsung Health Monitor app.²

To monitor blood pressure on the Galaxy Watch Active2, users will need to first calibrate with a traditional cuff. They will then be able to tap to “Measure” the blood pressure anytime, anywhere through pulse wave analysis via the Galaxy Watch Active2 wrist sensors.¹ The Samsung Health Monitor app analyzes the relationship between the calibration value and the blood pressure change to determine the blood pressure.³

When you measure your blood pressure with the Galaxy Watch Active2, the measurement results can be synced to the Samsung Health Monitor app on your Galaxy phone. You can track your blood pressure by days, weeks or months and choose to share this information with your doctor for review or consultation.

Electrocardiogram (ECG) tracking will also be supported on the Samsung Health Monitor app in South Korea within the third quarter of this year. Together, the ground-breaking blood pressure and ECG technology will help users monitor and manage their health by providing on-demand measurements.

It also means that the Galaxy Watch Active2 now boasts some of Samsung’s most advanced health and wellness capabilities to date, offering users a range of services to help track exercise, sleep, stress and much more.⁴ It provides users with an easy and convenient way to monitor their wellbeing and receive added health insights.

“The launch of the Samsung Health Monitor app demonstrates Samsung’s dedication to providing accessible and convenient healthcare for all by integrating advanced hardware and best-in-class software technology,” said TaeJong Jay Yang, Corporate SVP and Head of Health Team, Mobile Communications Business at Samsung Electronics. “We’re delighted that Galaxy Watch Active2 users in Korea can now access the new app and receive insights to help them manage their health. We look forward to expanding the app to all future Galaxy Watch products.”

To measure blood pressure, users must have the Samsung Health Monitor app installed on both the Galaxy Watch Active2 and the Galaxy smartphone. The Samsung Health Monitor app is automatically installed on the Galaxy Watch Active2 by updating the Watch Software to the latest version via the Galaxy Wearable app. The smartwatch app will then open a link, which will direct users to the smartphone app download page in the Galaxy Store app.

¹ To ensure accuracy, users should calibrate their device at least every four weeks.

² Requires Galaxy smartphone, running Android 7.0 or above and Galaxy Watch Active2 or upcoming Galaxy Watch device(s) to be paired.

³ Users should measure their blood pressure when at rest, as they would do with a traditional cuff, and refrain from measuring when they are working out, smoking or drinking.

⁴ Availability may vary by market.