Samsung Electronics’ Galaxy Watch has obtained medical device approval from the U.S. Food and Drug Administration (FDA).
The electronics giant on Feb. 10 announced that the sleep apnea measurement feature developed for the Galaxy Watch series has received De Novo authorization from the U.S. FDA.
De Novo authorization signifies initial approval, indicating that the safety and effectiveness of new healthcare technology have been comprehensively reviewed.
The feature focuses on the early detection of symptoms by measuring blood oxygen saturation during sleep using the BioActive Sensor in the Galaxy Watch. This marks the first time the FDA has approved a wearable device-targeted software medical device for sleep apnea.
Sleep apnea is a condition where breathing stops intermittently during sleep, disrupting the blood oxygen supply and reducing sleep quality. In severe cases, it can lead to various complications such as hypertension, heart disease, stroke, and cognitive disorders.
Samsung Electronics has announced that the sleep apnea measurement feature will be supported in the Galaxy Watch series through future updates to the Samsung Health Monitor app.
Samsung received approval for this feature as a software medical device from the Ministry of Food and Drug Safety in September last year.
This article was originally published on Feb. 10, 2024.
