Samsung Electronics said on Thursday that its Galaxy Watch series recently received approval from the Ministry of Food and Drug Safety (MFDS) for a feature that supports early detection of sleep apnea.
Sleep apnea is a condition in which breathing stops during sleep, interferes with the supply of oxygen to the blood, reduces sleep quality, and in severe cases can lead to complications such as high blood pressure, heart disease, stroke, or cognitive impairment.
The wearable's ability to help detect sleep apnea at an early stage has been granted software as a medical device (SaMD). SaMD refers to medical devices developed in the form of software that is embedded in devices to operate them as standalone devices that are installed and used on general-purpose equipment or devices such as mobile devices.
"The number of obstructive sleep apnea patients in Korea is estimated to be between 1 million and 2 million, but it is estimated that about 75 percent of them have not received an accurate diagnosis," said Professor Jung Yong-gi of Data Convergence and Future Medicine at Samsung Medical Center. "The sleep apnea early detection support function using smartwatches will provide an opportunity to dramatically improve treatment for sleep diseases by overcoming time, space, and cost constraints."
The feature uses the Galaxy Watch's bioactive sensor to measure blood oxygen saturation (SpO2) during sleep, analyze the pattern of changes in SpO2 values from apnea to hypopnea, and calculate an estimate of the apnea-hypopnea index (AHI) during sleep, to alert users to symptoms.
A Samsung Electronics official explained that to ensure data accuracy, users must sleep at least four hours per night for two nights within a 10-day period while wearing the watch. Additionally, the sleep apnea function is expected to be added to Galaxy Watch 5 and Watch 6 early 2024 through an update to the Samsung Health Monitor app.
"With this approval, we expect Galaxy Watch users to be able to detect related symptoms more easily and conveniently," said Samsung Electronics Vice President and Head of the Digital Health Team Park Hon. "Samsung Electronics will continue to strive to develop innovative technologies that help customers understand and manage their health comprehensively, including sleep."