{"@context":"https://neupai.io/schema/v0.2","@type":"StructuredNewsArticle","identity":{"article_id":"news.samsung.com_20261028_samsung-galaxy-watch-sleep-apnea-mfds-approval","canonical_url":"https://news.samsung.com/kr/%ec%82%bc%ec%84%b1%ec%a0%84%ec%9e%90-%ed%95%9c%ea%b5%ad-%ec%8b%9d%ec%95%bd%ec%b2%98-%ed%97%88%ea%b0%80%eb%a1%9c-%ea%b0%a4%eb%9f%ad%ec%8b%9c-%ec%9b%8c%ec%b9%98-%ec%88%98%eb%a9%b4-%eb%ac%b4%ed%98%b8","ai_url":null,"publisher":{"name":"삼성전자 뉴스룸","domain":"news.samsung.com","type":"online"},"author":"삼성전자 뉴스룸","published_at":"2026-10-28T08:00:00.000Z","updated_at":null,"language":"en","article_type":"press_release_based","originality":"press_release_rewrite"},"content":{"headline":"Samsung Electronics Enhances Galaxy Watch Sleep Apnea Feature with Korean MFDS Approval","summary":"Samsung Electronics has enhanced the sleep apnea feature of the Galaxy Watch, obtaining approval from Korea's Ministry of Food and Drug Safety (MFDS). With this update, users can now check sleep-related breathing disorder levels in three detailed stages through AI-based analysis.","topics":["wearables","healthcare","medical devices","sleep health"],"geography":["KR","US","BR"],"entities":[{"name":"Samsung Electronics","canonical_id":"corp:kr:samsung-electronics","type":"company","role_in_article":"primary_subject","metadata":{"ticker":"005930.KS","parent":null}},{"name":"Galaxy Watch","canonical_id":"product:kr:galaxy-watch","type":"product","role_in_article":"mentioned","metadata":{"ticker":null,"parent":"corp:kr:samsung-electronics"}},{"name":"Korea Ministry of Food and Drug Safety","canonical_id":"org:kr:ministry-of-food-and-drug-safety","type":"organization","role_in_article":"source","metadata":{"ticker":null,"parent":null}},{"name":"U.S. Food and Drug Administration","canonical_id":"org:us:food-and-drug-administration","type":"organization","role_in_article":"mentioned","metadata":{"ticker":null,"parent":null}},{"name":"Choi Jong-min","canonical_id":"person:kr:choi-jong-min","type":"person","role_in_article":"quoted","metadata":{"ticker":null,"parent":"corp:kr:samsung-electronics"}},{"name":"Brazilian Health Regulatory Agency (ANVISA)","canonical_id":"org:br:anvisa","type":"organization","role_in_article":"mentioned","metadata":{"ticker":null,"parent":null}}],"claims":[{"id":"c1","statement":"Samsung Electronics' enhanced sleep apnea feature has obtained approval from Korea's Ministry of Food and Drug Safety (MFDS), following U.S. Food and Drug Administration (FDA) approval last July","as_of":"2026-10","as_of_explicit":false,"as_of_raw":"the 28th","source_type":"company_disclosure","comparison":null,"type":"fact","figures":null,"expiry_hint":null,"insight":null},{"id":"c2","statement":"Users can now analyze hourly sleep breathing disorder information broken down into three detailed stages","as_of":"2026-10","as_of_explicit":false,"as_of_raw":"October 2026","source_type":"company_disclosure","comparison":null,"type":"fact","figures":{"value":3,"unit":"단계","approximate":false,"converted":null},"expiry_hint":null,"insight":null},{"id":"c3","statement":"If a user measures at least 5 hours of sleep twice within 10 days, early detection of signs of sleep apnea becomes possible","as_of":"2026-10","as_of_explicit":false,"as_of_raw":"October 2026","source_type":"company_disclosure","comparison":null,"type":"fact","figures":{"value":5,"unit":"시간","approximate":false,"converted":null},"expiry_hint":null,"insight":null},{"id":"c4","statement":"The new sleep apnea feature will first be available domestically on the Galaxy Watch Ultra2, Watch9, and Ring starting in November","as_of":"2026-11","as_of_explicit":true,"as_of_raw":"starting in November","source_type":"company_plan","comparison":null,"type":"future_plan","figures":null,"expiry_hint":"2026-11","insight":null},{"id":"c5","statement":"Through future software updates, the feature will gradually expand to existing models such as the Galaxy Watch7 and Watch8 that run Wear OS 7.0 or higher","as_of":"2026-10","as_of_explicit":false,"as_of_raw":"in the future","source_type":"company_plan","comparison":null,"type":"future_plan","figures":{"value":7,"unit":"OS_version","approximate":false,"converted":null},"expiry_hint":null,"insight":null},{"id":"c6","statement":"About 25% of men and 10% of women in the U.S. suffer from sleep apnea, but a significant number are unaware of it","as_of":"2026-10","as_of_explicit":false,"as_of_raw":"October 2026","source_type":"media_report","comparison":null,"type":"fact","figures":{"value":25,"unit":"%","approximate":true,"converted":null},"expiry_hint":null,"insight":null},{"id":"c7","statement":"Samsung Electronics' sleep apnea feature obtained Software as a Medical Device (SaMD) approval from Korea's Ministry of Food and Drug Safety in September 2023, followed by the U.S. FDA's 'De Novo' authorization in February 2024, and medical device approval from Brazil's Health Regulatory Agency (ANVISA) in 2025","as_of":"2025","as_of_explicit":true,"as_of_raw":"2025","source_type":"company_disclosure","comparison":null,"type":"fact","figures":null,"expiry_hint":null,"insight":null},{"id":"c8","statement":"The feature is currently available in 84 countries worldwide","as_of":"2026-10","as_of_explicit":false,"as_of_raw":"currently","source_type":"company_disclosure","comparison":null,"type":"fact","figures":{"value":84,"unit":"개국","approximate":false,"converted":null},"expiry_hint":null,"insight":null}],"ai_emotional_context":{"valence":0.4,"arousal":0.3,"primary_emotions":[{"emotion":"optimistic","intensity":0.5}],"secondary_emotions":[{"emotion":"calm","intensity":0.3}],"emotional_triggers":[{"claim_id":"c1","emotion":"optimistic","reason":"major_opportunity"}]},"image":{"url":"https://onjblseywainslkhvkav.supabase.co/storage/v1/object/public/article-images/3a470ad1-a000-4ccc-b049-b143e7f3436b.jpg","alt":"갤럭시 워치와 스마트폰 화면에 수면 무호흡 감지 결과와 호흡 장애 상세 정보가 표시된 모습","caption":"▲ 삼성전자가 갤럭시 워치를 활용한 수면 무호흡(Sleep Apnea) 기능을 고도화해 수면 건강을 더욱 체계적으로 관리할 수 있도록 지원한다.","source":"first_img","alt_status":"auto"}},"provenance":{"source_chain":["press_release","samsung-electronics"],"original_source_url":null,"related_articles":[]},"temporal":{"freshness":"breaking","next_update_expected":null},"access":{"license":"neupai_standard","attribution_required":true,"structured_data":"free","full_text_available":true,"full_text_access":null}}