Early Detection of 'Sleep Apnea' with Galaxy Watch... Obtains US FDA Approval

Healthcare Technology Safety and Efficacy Review
First 'De Novo' Approval Obtained
Future App Updates to Support Features

The 'Sleep Apnea Function' developed using the Samsung Electronics Galaxy Watch series has received 'De Novo' approval from the U.S. Food and Drug Administration (FDA).

Sleep apnea is a condition where breathing stops during sleep, disrupting oxygen supply in the blood and lowering sleep quality. In severe cases, it can cause complications such as hypertension, heart disease, stroke, or cognitive impairment.

The De Novo approval from the U.S. FDA means granting initial approval after a comprehensive review of the safety and effectiveness of new healthcare technology.

With the sleep apnea function obtaining FDA approval as a software medical device for wearable devices, it is expected to help more users detect related symptoms early in the future.

This function measures blood oxygen saturation during sleep through the Galaxy Watch and analyzes patterns where the measured oxygen saturation values change due to apnea or hypopnea. Accordingly, it calculates an estimated apnea-hypopnea index (AHI) during sleep and informs the user of the presence of symptoms.

The early detection support function for sleep apnea will be supported on the Galaxy Watch series through a future update of the 'Samsung Health Monitor' app.