Samsung Galaxy Watch (and Galaxy Ring)

[commercial]

biometric · food-service · 1 deployments in catalog

Field Advisory

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.

Form Factor

biometric

Lifecycle

commercial

Operational Reality

Audited

Deployments

1

Target Price

$399 (actual sale price)

  • COMMERCIAL

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.

Key facts & specs

15 entries
website
https://www.samsung.com/us/watches/compare/
maturity
commercial
lifecycle
active
manufacturer
Samsung Electronics
deployments count
1
Maturity stage
commercial
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: 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
F D A 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

Availability and pricing

price
$399 (actual sale price) · as of 2024-07-24
lead time
Not disclosed
sales model
Not disclosed
availability
Shipping now
units in field
Not disclosed
pricing Model
Not disclosed

Safety record

Safety Status
Zero incidents on record

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

Risk Metrics
Incidents: 0
Recalls: 0

FAQ

15 entries
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.

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.

Who makes Samsung Galaxy Watch (and Galaxy Ring)?

Samsung Galaxy Watch (and Galaxy Ring) is made by Samsung Electronics, based in Suwon, South Korea, founded in 1969.

Where is Samsung Galaxy Watch (and Galaxy Ring) deployed?

1 verified deployment of Samsung Galaxy Watch (and Galaxy Ring) is on the DEPLOY registry, including at Global.

Can you buy Samsung Galaxy Watch (and Galaxy Ring)?

Samsung Galaxy Watch (and Galaxy Ring) is available for purchase - a real sale price is on record (see the pricing section for the figure and its source).

Is Samsung Galaxy Watch (and Galaxy Ring) FDA cleared?

Samsung Galaxy Watch (and Galaxy Ring) has 3 regulatory records on the DEPLOY registry: FDA De Novo authorization (DEN230041), active; FDA De Novo authorization (DEN230041), granted; FDA 510(k) clearance (K230292), cleared. See the Regulatory filings section for each agency source.

What are alternatives to Samsung Galaxy Watch (and Galaxy Ring)?

On the DEPLOY registry, comparable biometric robots to Samsung Galaxy Watch (and Galaxy Ring) include Blackrock Neuroport Array, BrainQ Non-Invasive BCI, Neko Body Scan, RNS System.

How does Samsung Galaxy Watch (and Galaxy Ring) compare to Blackrock Neuroport Array?

Samsung Galaxy Watch (and Galaxy Ring) and Blackrock Neuroport Array (Blackrock Neurotech · 5 deployments) are both biometric robots on the DEPLOY registry. Samsung Galaxy Watch (and Galaxy Ring) has 1 verified deployment on record. Compare both records for specs, safety, deployments, and verified-vs-claimed autonomy.

Is Samsung Galaxy Watch (and Galaxy Ring) a top biometric?

On DEPLOY's intelligence score, which blends verified deployments, safety, adoption, media, and IP signals, Samsung Galaxy Watch (and Galaxy Ring) ranks in roughly the top 39% of biometric models tracked by the registry.

What is Samsung Galaxy Watch (and Galaxy Ring)'s maturity stage?

Samsung Galaxy Watch (and Galaxy Ring) is at the commercial stage on the DEPLOY maturity ladder (research, prototype, pilot, commercial, production). Commercial stage means production-grade deployments are operating at named customer sites.

Is Samsung Galaxy Watch (and Galaxy Ring) safe?

Samsung Galaxy Watch (and Galaxy Ring) has no incidents on record in the DEPLOY registry. This does not constitute a safety guarantee; it reflects the incidents DEPLOY has tracked and verified to date.

Does the Samsung Galaxy Watch have FDA-approved blood pressure monitoring?

No. Samsung has clarified that Galaxy Watch blood pressure monitoring is not FDA-approved in the US. The feature is classified as a wellness tool, not a medical device. Samsung Galaxy Watch has FDA De Novo clearance (DEN230041) for sleep apnea detection. Samsung Health connects health data with AI-based insights.

Deployments

1 entry

Sectors & applications

1 entry