{"id":"df95c54f-78bf-4e3d-a232-80c8385c6e1d","companyId":"98473e95-cf04-4165-ba07-fb53f1e9969b","modelName":"Samsung Galaxy Watch (and Galaxy Ring)","slug":"samsung-galaxy-watch","description":"Samsung Electronics' Galaxy Watch and Galaxy Ring are biometric-primary devices with FDA-cleared cardiac and sleep AI on the Watch, recorded in the new biometric form factor. The Galaxy Watch 7 and Watch Ultra, both from July 2024, carry a BioActive sensor combining optical heart-rate, electrical ECG, and bioimpedance sensing, while the Galaxy Ring announced in July 2024 carries an accelerometer, optical heart-rate, and skin-temperature sensor for sleep, heart rate, and an Energy Score but has no ECG and no FDA-cleared medical features. The Watch's clearances, held through the Samsung Health Monitor app, are an on-demand ECG cleared in 2021, an Irregular Heart Rhythm Notification for atrial fibrillation announced in May 2023, and a sleep-apnea feature authorized via FDA De Novo on February 9, 2024 as the first such feature authorized by the FDA, for moderate-to-severe obstructive sleep apnea in adults 22 and older. A significant cap-flag applies to blood pressure: the Galaxy Watch's cuff-calibrated blood-pressure feature was available internationally for years but not FDA-cleared in the US, and when Samsung launched it to US users around March 31, 2026 it did so explicitly without FDA clearance under the agency's general-wellness low-risk-device policy, so it is a wellness carve-out rather than a medical clearance and marketing it as medical-grade blood pressure exceeds its regulatory status, while the Galaxy Ring carries no FDA-cleared medical features and should not be conflated with the Watch's clearances. The devices are sold by hardware purchase with no subscription, Samsung's clinical-validation posture is growing with a strong regulatory record but thinner independent peer-review than Apple, and the exact clearance number for the atrial-fibrillation feature and whether the US blood-pressure wellness launch will later pursue FDA clearance are not verified.","formFactor":"biometric","industryVertical":null,"environment":null,"maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{"notes":[{"label":"FDA clearances (US, via Samsung Health Monitor)","value":"ECG (on-demand single-lead): cleared 2021. Irregular Heart Rhythm Notification (AFib): cleared, announced May 2023. Sleep Apnea: FDA De Novo Feb 9 2024 - the FIRST sleep-apnea detection feature authorized by FDA (mod-severe OSA, adults 22+, software-only mobile medical app)."},{"label":"CAP-FLAG (US BP = wellness, NOT cleared)","value":"Galaxy Watch blood-pressure (cuff-calibrated, PPG) was internationally available for years but NOT FDA-cleared in the US. NEW: Samsung launched BP to US users ~Mar 31 2026 but EXPLICITLY WITHOUT FDA clearance, under FDA's 'General Wellness: Low-Risk Devices' policy. This is a WELLNESS carve-out, not a medical clearance - marketing it as medical-grade BP exceeds its regulatory status. The Galaxy RING carries NO FDA-cleared medical features (wellness/lifestyle tracker; don't conflate with the Watch's clearances)."},{"label":"Verification posture","value":"Boundary: biometric-primary + AI-augmented. Clinical posture: GROWING (strong regulatory record - first FDA-authorized sleep apnea - but thinner independent peer-review than Apple; much evidence is in regulatory submissions). NOT verified: exact K-number/date for the AFib clearance; whether the US BP wellness launch will later pursue FDA clearance."}],"specs":"Galaxy Watch 7 + Watch Ultra (Jul 2024) + Galaxy Ring (Jul 2024). Watch BioActive sensor (optical HR + electrical ECG + bioimpedance). Galaxy Ring: accelerometer + optical HR + skin temp (sleep/HR/Energy Score; NO ECG, NO FDA-cleared features). Health features via Samsung Health Monitor app (holds the FDA clearances). Hardware purchase; NO subscription.","battery":"80 h","weight_kg":0.034,"formFactor":"biometric (biometric-primary smartwatch + smart ring; FDA-cleared cardiac/sleep AI on the Watch)","fda_clearance":{"source":"https://www.fda.gov/medical-devices/recently-approved-devices/galaxy-watch-ecg-k223283","status":"cleared","details":"FDA-cleared ECG (K223283, 2022); blood pressure monitoring (De Novo, 2022); sleep apnea detection (2024). Galaxy Ring NOT FDA-cleared as of 2026.","audited_at":"2026-06-07","source_name":"FDA","health_claim":"ECG, blood pressure, sleep apnea detection on select models. Wellness primary with FDA-cleared subsets.","verification_posture":"verified"}},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://aasm.org/samsung-galaxy-watch-sleep-apnea-feature-receives-fda-authorization/","title":"Samsung Galaxy Watch sleep-apnea feature FDA De Novo authorized (Feb 9 2024; first of its kind; mod-severe OSA 22+)","sourceName":"AASM"},{"url":"https://techcrunch.com/2023/05/08/samsungs-irregular-heart-rhythm-notification-galaxy-watch-fda-clearance/","title":"Samsung Irregular Heart Rhythm Notification (AFib) FDA-cleared (announced May 2023)","sourceName":"TechCrunch"},{"url":"https://www.androidauthority.com/samsung-galaxy-watch-blood-pressure-monitoring-us-rollout-3653403/","title":"Samsung Galaxy Watch BP launches in US (~Mar 31 2026) WITHOUT FDA clearance (wellness)","sourceName":"Android Authority"},{"url":"https://www.mobihealthnews.com/news/samsung-announces-new-galaxy-ring-and-galaxy-watch-ultra","title":"Samsung Galaxy Ring announced (Jul 10 2024; sleep/HR/temp; no ECG, no FDA-cleared medical features)","sourceName":"MobiHealthNews"},{"url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN230041","title":"Samsung Sleep Apnea Feature De Novo DEN230041 (granted Feb 6 2024; created the OTC sleep-apnea-risk device type; predicate for Apple K240929)","sourceName":"FDA 510(k)/De Novo Database"},{"url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230292","title":"Samsung ECG Monitor with Irregular Heart Rhythm Notification 510(k) K230292 (May 2 2023)","sourceName":"FDA 510(k)/De Novo Database"},{"url":"https://www.samsung.com/us/watches/compare/","title":"Compare Smartwatches","sourceName":"Samsung (official)"}],"aliases":["Samsung Galaxy Watch","Galaxy Watch 7","Galaxy Watch Ultra","Galaxy Ring"],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[{"label":"Form factor","value":"biometric (smartwatch + smart ring)"},{"label":"FDA clearances","value":"ECG cleared 2021; Irregular Heart Rhythm Notification (AFib) May 2023; Sleep Apnea FDA De Novo Feb 9 2024"},{"label":"Sensor suite","value":"Watch BioActive sensor: optical HR + electrical ECG + bioimpedance; Galaxy Ring: accelerometer + optical HR + skin temp"},{"label":"Production target","value":"Galaxy Watch 7 and Watch Ultra July 2024; Galaxy Ring July 2024"},{"label":"Price","value":"Hardware purchase; no subscription"}],"createdAt":"2026-06-03T22:31:28.053Z","updatedAt":"2026-07-15T13:23:03.233Z","unitsInFieldClaimed":null,"unitsInFieldVerified":null,"unitsManufacturedClaimed":null,"unitsManufacturedVerified":null,"unitsAsOf":null,"unitsSource":null,"salesModel":null,"priceUndisclosedSince":null,"autonomyClass":null,"autonomyStatement":null,"autonomyStatementSource":null,"demoForensics":null,"exportControlClass":null,"minCommitment":null,"warrantyTerms":null,"serviceModel":null,"productionRateClaimed":null,"productionRateEvidenced":null,"teleopRatioDisclosed":null,"interventionRateDisclosed":null,"jsonLd":{"@context":"https://schema.org","@type":"Product","@id":"https://registry.deploy.report/models/samsung-galaxy-watch","url":"https://registry.deploy.report/models/samsung-galaxy-watch","name":"Samsung Galaxy Watch (and Galaxy Ring)","alternateName":["Samsung Galaxy Watch","Galaxy Watch 7","Galaxy Watch Ultra","Galaxy Ring"],"description":"Samsung Electronics' Galaxy Watch and Galaxy Ring are biometric-primary devices with FDA-cleared cardiac and sleep AI on the Watch, recorded in the new biometric form factor. The Galaxy Watch 7 and Watch Ultra, both from July 2024, carry a BioActive sensor combining optical heart-rate, electrical ECG, and bioimpedance sensing, while the Galaxy Ring announced in July 2024 carries an accelerometer, optical heart-rate, and skin-temperature sensor for sleep, heart rate, and an Energy Score but has no ECG and no FDA-cleared medical features. The Watch's clearances, held through the Samsung Health Monitor app, are an on-demand ECG cleared in 2021, an Irregular Heart Rhythm Notification for atrial fibrillation announced in May 2023, and a sleep-apnea feature authorized via FDA De Novo on February 9, 2024 as the first such feature authorized by the FDA, for moderate-to-severe obstructive sleep apnea in adults 22 and older. A significant cap-flag applies to blood pressure: the Galaxy Watch's cuff-calibrated blood-pressure feature was available internationally for years but not FDA-cleared in the US, and when Samsung launched it to US users around March 31, 2026 it did so explicitly without FDA clearance under the agency's general-wellness low-risk-device policy, so it is a wellness carve-out rather than a medical clearance and marketing it as medical-grade blood pressure exceeds its regulatory status, while the Galaxy Ring carries no FDA-cleared medical features and should not be conflated with the Watch's clearances. The devices are sold by hardware purchase with no subscription, Samsung's clinical-validation posture is growing with a strong regulatory record but thinner independent peer-review than Apple, and the exact clearance number for the atrial-fibrillation feature and whether the US blood-pressure wellness launch will later pursue FDA clearance are not verified.","identifier":"df95c54f-78bf-4e3d-a232-80c8385c6e1d","category":"biometric","publisher":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"verified","maturity_stage":"commercial","lifecycle_state":"active","architectural_position":{"cohort":"biometric","sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":7,"primary_source_types":["primary-company-ir","primary-fda-database","secondary-industry-publication"]}}}