Samsung Galaxy
Samsung Electronics makes Galaxy Watch smartwatches (Watch9, Watch Ultra2), the Galaxy Ring and the Galaxy Fit band. They work with its Samsung Health and Samsung Health Monitor apps, and the hearing features run on its Galaxy Buds. Samsung makes its money from hardware: Samsung says Galaxy Ring data and insights sit in Samsung Health 'without a subscription', and no paid Samsung Health tier was found. The work sits in the Mobile eXperience (MX) business, inside the Device eXperience (DX) division. The division holds several FDA clearances, including ECG, irregular rhythm notification, sleep apnea and an OTC hearing aid, and since July 2025 has been building a 'connected care' platform around its acquisition of Xealth.
5 devices · 8 clearances on file · researched 2026-11-08
- Headquarters
- Suwon, South Korea
- Founded
- 1969
- Ownership
- Division of Samsung Electronics Co., Ltd. · KRX:005930
- Website
- samsung.com/us/watches
- Focus
- fitness, sleep, heart health, medical, sports performance, outdoor/navigation
- Membership
- Samsung Health · optional ↗Samsung (July 2024) says Galaxy Ring data and insights are in Samsung Health 'without a subscription'. No paid tier is listed. Watch9/Ultra2 buyers get third-party trials: 60-day Strava, and 2-month iFIT in 23 markets.
- Leadership
- TM Roh (Roh Tae-moon) President and Acting Head of the Device eXperience (DX) Division (July 2025); Wikipedia now lists him as president and CEO, DX ↗
Hon Pak Senior Vice President and Head of the Digital Health Team, Mobile eXperience (MX) Business ↗ - Employees
- 259,149 (2025, Samsung Electronics group total, not wearables) ↗
- Revenue
- KRW 333,610,000,000,000 (2025, company total (Samsung Electronics); wearables revenue not disclosed) ↗
1
Devices
Each device as the maker lists it; a dash means no source states the figure.
| Device | Form | Status | Sensors | Battery | Price |
|---|---|---|---|---|---|
| Galaxy Watch9 (40 mm / 44 mm) ↗2026-07First Galaxy Watch on Qualcomm Snapdragon Wear Elite; 390/445 mAh batteries; display up to 3,000 nits. Samsung's own Q&A answer on the store page says 'about 40 hours' without AOD and 'up to 30 hours' with it | watch | On sale | Samsung BioActive Sensor (optical bio-signal + electrical heart signal + bioelectrical impedance analysis), temperature, accelerometer, barometer, gyro, geomagnetic, light, GPS | — | $379.99US$379.99 for 40 mm Bluetooth; 44 mm BT $409.99; 40 mm LTE $429.99; 44 mm LTE $459.99 (samsung.com/us MSRP, 2026-11-08) |
| Galaxy Watch Ultra2 (47 mm) ↗2026-07Rugged titanium dive-rated model with an 800 mAh battery (35% more than the previous Ultra) and a display up to 5,000 nits; Samsung's store Q&A says 'up to 60 hours' with AOD on | watch | On sale | Samsung BioActive Sensor (optical bio-signal + electrical heart signal + bioelectrical impedance analysis), temperature, accelerometer, barometer, gyro, geomagnetic, light, GPS (L1+L5 dual-frequency) | — | $699.99US$699.99, 47 mm LTE titanium (samsung.com/us MSRP, 2026-11-08) |
| Galaxy Watch8 / Watch8 Classic ↗2025-07Previous generation, still sold on samsung.com/us; the watch used in the MGH GLP-1 body-composition study; adds the Antioxidant Index | watch | On sale | Samsung BioActive Sensor, bioelectrical impedance analysis | — | — |
| Galaxy Ring ↗2024-07Titanium ring, sizes 5–13; up to 7 days battery for sizes 12–13 (6 days for smaller sizes); since Nov 2026 the first smart ring to offer sleep apnea risk detection | ring | On sale | accelerometer, PPG (optical HR), skin temperature | 7 d | $399.99US$399.99 all sizes and colours (samsung.com/us MSRP, 2026-11-08); free sizing kit |
| Galaxy Fit3 ↗2024-02Budget band running FreeRTOS, with a 1.6-inch AMOLED screen and fall detection; Android only | band | On sale | optical HR, accelerometer, ambient light | 13 d | INR 4,999 at India launch (Feb 2024); no US listing found on samsung.com/us |
2
Regulatory clearances
Health features a regulator has cleared, with the decision number.
| Feature | Device | Agency | Type | Number | Date |
|---|---|---|---|---|---|
| ECG (ECG Monitor App) ↗ | Samsung Health Monitor (Galaxy Watch) | FDA | 510(k) | K201168 | 2020-08 |
| ECG with irregular heart rhythm notification ↗ | Samsung Health Monitor (Galaxy Watch) | FDA | 510(k) | K230292 | 2023-05 |
| ECG ↗ | Samsung ECG App v1.3 | FDA | 510(k) | K240909 | 2024-08 |
| sleep apnea (signs of moderate to severe OSA) ↗ | Samsung Health Monitor (Galaxy Watch) | FDA | De Novo | DEN230041 | 2024-02 |
| sleep apnea (OTC risk assessment) ↗ | Sleep Apnea Feature v2.0 (Galaxy Watch and Galaxy Ring) | FDA | 510(k) | K261011 | 2026-07 |
| sleep apnea ↗ | Sleep Apnea Feature v2.0 (Galaxy Watch and Galaxy Ring) | other | Korea MFDS approval | — | 2026-10 |
| OTC hearing aid (air-conduction hearing aid software) ↗ | Galaxy Buds Hearing Aid feature | FDA | 510(k) | K261187 | 2026-07 |
| S Health app (FDA product code DRG) ↗ | S Health | FDA | 510(k) | K132148 | 2013-12 |
3
Partnerships
Teams, leagues, insurers and health systems that use or resell the devices.
- 2025-04Stanford Medicine — Research project building on the Galaxy Watch obstructive sleep apnea feature ↗
- 2026-05Massachusetts General Hospital Diabetes Research Center — Joint study: Galaxy Watch8 BIA body-composition monitoring of muscle loss in 100 adults starting GLP-1RA therapy ↗
- 2026-06Alcedis (clinical research organization) — Partnership to turn wearable biometrics into clinical-trial endpoints for pharma research ↗
- 2026-07Strava / iFIT — 60-day Strava and 2-month iFIT subscription trials bundled with Galaxy Watch9 and Watch Ultra2 ↗
4
Dated facts
Launches, lawsuits, acquisitions and filings, newest first.
- 2026-11Updated Sleep Apnea feature (FDA-cleared July 2026, Korea MFDS-approved Oct 2026) went live on Galaxy Watch and Galaxy Ring; Samsung calls it the first sleep apnea risk detection on a smart ring. ↗
- 2026-08Galaxy Buds Hearing Aid feature received FDA clearance as an OTC hearing aid for adults 18+ with perceived mild to moderate hearing loss. ↗
- 2026-07Galaxy Watch9 and Watch Ultra2 unveiled at Galaxy Unpacked in London on 22 July 2026; general availability from 7 Aug 2026. ↗
- 2026-03Cuff-calibrated blood pressure monitoring (recalibration every 28 days) rolled out to US Galaxy Watch4-and-newer users through the Samsung Health Monitor app. Samsung states it is 'not intended to prevent or diagnose high blood pressure'. ↗
- 2025-12Ouraring Inc. filed a Section 337 complaint on 18 Nov 2025 against Samsung Electronics Co., Ltd. and Samsung Electronics America (plus Reebok, Zepp Health and Nexxbase) over smart rings. The ITC instituted Inv. No. 337-TA-1468 on four Oura patents, and Oura seeks exclusion and cease-and-desist orders. ↗
- 2025-12Samsung countersued Oura in the Eastern District of Texas, asserting six patents (two acquired, four Samsung-originated). ↗
- 2025-12Samsung Electronics Co., Ltd. and Samsung Electronics America filed their own Section 337 complaint against Ouraring, Inc. and Ōura Health Oy on 15 Dec 2025 (amended 5 Jan 2026), asserting US Patents 10,642,359, 10,945,677, 10,231,675 and 10,978,789. The ITC instituted Inv. No. 337-TA-1478 (notice published 16 Jan 2026), and Samsung seeks a limited exclusion order and cease-and-desist orders. ↗
- 2025-07Samsung agreed to acquire Xealth, a Providence spin-out healthcare integration platform with more than 500 US hospitals and 70+ digital health partners; the price was not disclosed. ↗
- 2025-03A US court (N.D. Cal.) threw out Samsung's declaratory-judgment action against Oura because Oura had not specifically threatened patent enforcement. ↗
- 2024-07Galaxy Ring announced at Galaxy Unpacked in Paris alongside Galaxy Watch7 and Galaxy Watch Ultra. ↗
5
Not yet confirmed
Claims seen in only one non-official place. Shown so they can be checked, not as findings.
- Initial determination in Oura's ITC case (337-TA-1468) expected 20 Nov 2026, and in Samsung's case (337-TA-1478) in Jan 2027: seen only in a web-search summary of sammyfans.com (barred to this crawler), not read.
- Samsung withdrew US 10,945,677 from 337-TA-1478 by an order final in Oct 2026: seen only in a web-search summary of the5krunner.com (13 Oct 2026), not read.
- Samsung Health paid premium tier 'being explored' (Hon Pak interview, June 2025): only secondary press (gsmarena/sammobile) in search results, not read; no paid tier exists on Samsung's pages.
- ipfray (Jul 2026) headline 'final Samsung IPR fails' against an Oura patent: headline only, body paywalled.
- Samsung's E.D. Tex. suit: ipfray lists six patents; one web-search summary said twelve. Six is used.
S
Sources
Retrieved 2026-11-08.
- openFDA 510(k)/De Novo records, applicant Samsung Electronics — US FDA (openFDA)
- Certain Smart Wearable Devices...; Institution of Investigation (337-TA-1468) — Federal Register / USITC
- Certain Wearable Devices; Institution of Investigation (337-TA-1478) — Federal Register / USITC
- Oura Files ITC Action Against Samsung, Reebok, Zepp Health, and Nexxbase — Oura
- Samsung retaliates against Oura's ITC complaint with own E.D. Tex. patent infringement allegations — ip fray
- Samsung Galaxy Watch Ultra2 and Watch9: Your Health Companion on the Wrist — Samsung Mobile Press
- Galaxy Z Fold8 Ultra, Fold8, Flip8, Watch Ultra2 and Watch9 global launch — Samsung Mobile Press
- Samsung's Expanded Wearables Portfolio Unlocks Intelligent Health Experiences for All — Samsung Mobile Press
- Upgraded Sleep Apnea Feature Now Available on Galaxy Ring — Samsung Mobile Press
- Galaxy Buds Hearing Aid feature cleared by FDA — Samsung Mobile Press
- Samsung's Blood Pressure Monitoring Feature Now Available to U.S. Users — Samsung Mobile Press
- Samsung's Sleep Apnea Feature on Galaxy Watch First of Its Kind Authorized by US FDA — Samsung Mobile Press
- Samsung Electronics Acquires Xealth — Samsung Mobile Press
- Samsung Announces Collaboration With Stanford Medicine — Samsung Mobile Press
- Samsung and Massachusetts General Hospital GLP-1 study — Samsung Mobile Press
- Samsung Partners With Alcedis — Samsung Mobile Press
- Galaxy Watch9 buy page — Samsung US
- Galaxy Watch Ultra2 buy page — Samsung US
- Galaxy Ring buy page — Samsung US
- Samsung launches the Galaxy Fit3 in India — GSMArena
- Samsung Electronics — Wikipedia