Deployment

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.

Samsung Galaxy Watch (and Galaxy Ring) by Samsung Electronics · Catalog entry · 1 source · not yet field-verified