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Samsung Galaxy Watch (and Galaxy Ring)

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…

Track Samsung Galaxy Watch (and Galaxy Ring)
Manufacturer
Samsung Electronics
Form factor
biometric
Maturity
commercial
Lifecycle
active
Deployments
1
Website
samsung.com ↗

Overview

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.

Verified vs. claimed

Maturity stage
commercial(Commercially deployed with revenue-generating operations.)
Verified deployments
1 deployment on file
Sources on file
7 sources, view all

Key facts

Form factor

biometric (smartwatch + smart ring)

FDA clearances

ECG cleared 2021; Irregular Heart Rhythm Notification (AFib) May 2023; Sleep Apnea FDA De Novo Feb 9 2024

Sensor suite

Watch BioActive sensor: optical HR + electrical ECG + bioimpedance; Galaxy Ring: accelerometer + optical HR + skin temp

Production target

Galaxy Watch 7 and Watch Ultra July 2024; Galaxy Ring July 2024

Price

Hardware purchase; no subscription

Specs

Notes

FDA clearances (US, via Samsung Health Monitor): 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)., CAP-FLAG (US BP = wellness, NOT cleared): 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)., Verification posture: 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

Form Factor

biometric (biometric-primary smartwatch + smart ring; FDA-cleared cardiac/sleep AI on the Watch)

Fda clearance

Source: fda.gov 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

Data & sources

Press releases

1

News coverage

1

Government records

2

Web sources

3

7 sources backing this record.View all →

Availability and pricing

Availability
Shipping now
Price
$399 (actual sale price)as of 2024-07-24
Units in field
Not disclosed
Sales model
Not disclosed
Lead time
Not disclosed

Pricing

One-time purchase

$399 USDactual sale priceas of 2024-07-24

Source: Samsung Galaxy Ring launched July 24 2024 at $399; no subscription required; available in Titanium Black, Silver, Gold

History

Price status: actual-sale-price = real published price at time of sale; manufacturer-target = vendor target, not yet realized; analyst-estimate = third-party projection, not a vendor figure; not-announced = no price on record.

Prices verified as of Jul 24, 2024

Deployments (1)

Samsung Galaxy Watch (and Galaxy Ring) on the deployment map

Where Samsung Galaxy Watch (and Galaxy Ring) is verified operating. Explore the deployment map by place and type.

Recent activity

Every change to this record is dated, sourced, and independently verified where marked.

Full change history →

Deployment-verified media (3)

PRIMARY SOURCE
Courtesy of Samsung

Samsung's how-to for the Energy Score feature on the Galaxy Watch7. Energy Score is a Galaxy AI wellness metric, not an FDA-cleared medical feature; Samsung's feature-scoped clearances are ECG, irregular-heart-rhythm notification, and sleep-apnea detection.

From deployment: Global

PRIMARY SOURCE
Courtesy of Samsung

Samsung's how-to for sleep tracking on the Galaxy Watch7. Sleep stages and sleep score are wellness metrics, not medical-grade, and are distinct from Samsung's separately FDA-authorized sleep-apnea detection feature.

From deployment: Global

PRIMARY SOURCE
Courtesy of Samsung

Samsung's introduction of the Galaxy Ring. On Samsung wearables, ECG and irregular-heart-rhythm notifications are FDA-cleared; the Galaxy Ring's sleep and energy metrics are wellness-grade.

From deployment: Global

Regulatory filings (3)

Safety record

No incidents on record for Samsung Galaxy Watch (and Galaxy Ring).

Only active incidents are counted. Retracted incidents are excluded from this summary but remain reachable at their canonical URLs.

Sources (7)

  1. https://aasm.org/samsung-galaxy-watch-sleep-apnea-feature-receives-fda-authorization/
  2. https://techcrunch.com/2023/05/08/samsungs-irregular-heart-rhythm-notification-galaxy-watch-fda-clearance/
  3. https://www.androidauthority.com/samsung-galaxy-watch-blood-pressure-monitoring-us-rollout-3653403/
  4. https://www.mobihealthnews.com/news/samsung-announces-new-galaxy-ring-and-galaxy-watch-ultra
  5. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN230041
  6. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230292
  7. https://www.samsung.com/us/watches/compare/

Compare Samsung Galaxy Watch (and Galaxy Ring)

Common questions

What is Samsung Galaxy Watch (and Galaxy Ring)?
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.
How much does Samsung Galaxy Watch (and Galaxy Ring) cost?
Samsung Galaxy Watch (and Galaxy Ring) is listed at $399 on the DEPLOY registry. This is an actual sale price on record.
Samsung Galaxy Ring launched July 24 2024 at $399; no subscription required; available in Titanium Black, Silver, Gold
Is Samsung Galaxy Watch (and Galaxy Ring) actually deployed in the real world?
Yes. Samsung Galaxy Watch (and Galaxy Ring) is independently verified in real-world operation on the DEPLOY registry, confirmed at named deployment sites with primary sources: not a concept, render, or demo-only.
Is Samsung Galaxy Watch (and Galaxy Ring) autonomous or teleoperated?
Partly. DEPLOY verifies Samsung Galaxy Watch (and Galaxy Ring) operating autonomously for Detects irregular heart rhythm. Other capabilities (Tracks heart health and Tracks sleep) are only demonstrated under teleoperation or remain vendor claims, not independently verified as autonomous.
What are the specs of Samsung Galaxy Watch (and Galaxy Ring)?
Samsung Galaxy Watch (and Galaxy Ring)'s recorded specifications on the DEPLOY registry: Battery: 80 h; Weight: 0.034 kg. See the Specs section for the full sourced set.
Methodology: Verified · 7 sources (3 primary) · last reviewed 2026-07-15

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-07-15

Maturity + lifecycle

Maturity stage: commercial

Lifecycle: active

Architectural position

Cohort: biometric

Sources by quality tier

3
unclassified
Unclassified source
2
primary-fda-database
FDA database
1
secondary-industry-publication
Industry publication
1
primary-company-ir
Company IR disclosure

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Samsung Galaxy Watch (and Galaxy Ring).

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