Withings ScanWatch

[commercial]

biometric · food-service · 1 deployments in catalog

Field Advisory

FDA clearances: ECG app: FDA-cleared Oct 2021 (single-channel; classifies AFib/sinus rhythm/high HR; adults 22+). July 2025 update: ScanWatch 2 ECG cleared OTC - US users no longer need a board-certified cardiologist to activate ECG; new AFib algorithm gives 8 classifications (up from 4). SpO2: FDA-cleared (supports tracking blood-oxygen + breathing disturbances at night)., CAP-FLAG + clean contrast: 'Breathing disturbances detection' is a SCREENING AID, not a sleep-apnea DIAGNOSIS - framing it as apnea diagnosis exceeds scope. Clean contrast to Apple: Withings' SpO2/ECG were NEVER disabled in the US (not party to the Masimo dispute); the notable 2025 regulatory event was a POSITIVE OTC liberalization, not a restriction., Verification posture: Boundary: biometric-primary + AI-augmented. Clinical posture: SUBSTANTIAL-for-size (strong clinical-study framing; multiple ScanWatch SpO2/apnea validation studies; CE medical marking). NOT verified: exact K-numbers/dates for ScanWatch 2 SpO2 + temperature clearances (K240795/K240909 seen but date-to-feature mapping not fully nailed); standard ScanWatch Nova + ScanWatch 2 US list prices (approximate).

Manufacturer

Withings

Form Factor

biometric

Lifecycle

commercial

Operational Reality

Audited

Deployments

1

Target Price

$370 (actual sale price)

  • COMMERCIAL
  • RESEARCH

Description

Withings, a French consumer-health-electronics company founded in 2008 and independent again since 2018 after being bought back from Nokia, makes the ScanWatch line of biometric-primary hybrid analog smartwatches with cardiac and respiratory AI augmentation, recorded in the new biometric form factor. The ScanWatch 2 and ScanWatch Nova pair an analog dial with optical heart-rate, electrical ECG, blood-oxygen, and continuous temperature sensors on roughly a 30-day battery. Their FDA clearances are the ECG app, cleared in October 2021 to classify atrial fibrillation, sinus rhythm, and high heart rate for adults 22 and older, updated in July 2025 so that the ScanWatch 2 ECG is cleared over the counter, no longer requiring a board-certified cardiologist to activate, with a new eight-classification atrial-fibrillation algorithm, plus a cleared blood-oxygen feature that supports tracking breathing disturbances at night. A cap-flag applies because the breathing-disturbance detection is a screening aid rather than a sleep-apnea diagnosis, and framing it as diagnosis exceeds scope. Withings offers a clean contrast to Apple, since its blood-oxygen and ECG features were never disabled in the US as it is not party to the Masimo dispute, and the notable 2025 regulatory event was a positive over-the-counter liberalization rather than a restriction. It sells by hardware purchase with an optional Withings+ membership, its clinical-validation posture is substantial for its size with strong study framing and CE medical marking, and the exact clearance numbers and dates for the ScanWatch 2 blood-oxygen and temperature features and the standard US list prices are approximate and not fully verified.

Key facts & specs

16 entries
website
https://support.withings.com/hc/en-us/articles/16780197080209-ScanWatch-2-ECG-Frequently-Asked-Questions-FAQ-U-S-Only
maturity
commercial
lifecycle
active
manufacturer
Withings
deployments count
1
Maturity stage
commercial
Specs
ScanWatch 2 (~$349) + ScanWatch Nova (Nova Brilliant $599.95, Nov 2024). Hybrid analog-dial + sensor watches: PPG optical HR, electrical ECG, SpO2, TempTech24/7 continuous temperature; ~30-day battery. AI/health: ECG (AFib/sinus/high-HR), SpO2 + breathing-disturbance detection, temperature trends. Founded 2008, France (Issy-les-Moulineaux); independent since 2018 (bought back from Nokia). Hardware purchase; Withings+ ($9.95/mo) optional.
Battery
35 days
Weight kg
0.053
Form Factor
biometric (biometric-primary hybrid analog smartwatch + AI; ECG/SpO2 cleared)
Fda clearance
Source: https://www.fda.gov/medical-devices/recently-approved-devices/withings-scanwatch-ecg-k210580; Status: cleared; Details: FDA-cleared ECG (K210580, 2021); SpO2 monitoring. CE mark Class IIa medical device in EU.; Audited at: 2026-06-07; Source name: FDA; Health claim: ECG + SpO2 + sleep apnea detection. Positioned as medical-grade wellness hybrid.; Verification posture: verified
Battery life
~30 days
Price
ScanWatch 2 ~$349; ScanWatch Nova Brilliant $599.95
Sensor suite
PPG optical HR, electrical ECG, SpO2, TempTech24/7 continuous temperature
F D A clearances
ECG app cleared Oct 2021 (K210580); ScanWatch 2 ECG cleared OTC July 2025; SpO2 FDA-cleared
Membership
Withings+ optional at $9.95/mo

Availability and pricing

price
$370 (actual sale price) · as of 2026-06-17
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

1 recall on record (1 moderate). Most recent: Dec 2022.

Risk Metrics
Incidents: 0
Recalls: 1
Latest: Dec 2022
moderate: 1

FAQ

14 entries
What is Withings ScanWatch?

Withings, a French consumer-health-electronics company founded in 2008 and independent again since 2018 after being bought back from Nokia, makes the ScanWatch line of biometric-primary hybrid analog smartwatches with cardiac and respiratory AI augmentation, recorded in the new biometric form factor. The ScanWatch 2 and ScanWatch Nova pair an analog dial with optical heart-rate, electrical ECG, blood-oxygen, and continuous temperature sensors on roughly a 30-day battery. Their FDA clearances are the ECG app, cleared in October 2021 to classify atrial fibrillation, sinus rhythm, and high heart rate for adults 22 and older, updated in July 2025 so that the ScanWatch 2 ECG is cleared over the counter, no longer requiring a board-certified cardiologist to activate, with a new eight-classification atrial-fibrillation algorithm, plus a cleared blood-oxygen feature that supports tracking breathing disturbances at night. A cap-flag applies because the breathing-disturbance detection is a screening aid rather than a sleep-apnea diagnosis, and framing it as diagnosis exceeds scope. Withings offers a clean contrast to Apple, since its blood-oxygen and ECG features were never disabled in the US as it is not party to the Masimo dispute, and the notable 2025 regulatory event was a positive over-the-counter liberalization rather than a restriction. It sells by hardware purchase with an optional Withings+ membership, its clinical-validation posture is substantial for its size with strong study framing and CE medical marking, and the exact clearance numbers and dates for the ScanWatch 2 blood-oxygen and temperature features and the standard US list prices are approximate and not fully verified.

How much does Withings ScanWatch cost?

Withings ScanWatch is listed at $370 on the DEPLOY registry. This is an actual sale price on record.

Is Withings ScanWatch actually deployed in the real world?

Yes. Withings ScanWatch 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.

What are the specs of Withings ScanWatch?

Withings ScanWatch's recorded specifications on the DEPLOY registry: Battery: 35 days; Weight: 0.053 kg. See the Specs section for the full sourced set.

Who makes Withings ScanWatch?

Withings ScanWatch is made by Withings, based in Issy-les-Moulineaux, France, founded in 2008.

Where is Withings ScanWatch deployed?

1 verified deployment of Withings ScanWatch is on the DEPLOY registry, including at Global.

Can you buy Withings ScanWatch?

Withings ScanWatch is available for purchase - a real sale price is on record (see the pricing section for the figure and its source).

Is Withings ScanWatch FDA cleared?

Withings ScanWatch has 2 regulatory records on the DEPLOY registry: FDA 510(k) clearance (K201456), cleared; FDA 510(k) clearance (K201456), cleared. See the Regulatory filings section for each agency source.

What are alternatives to Withings ScanWatch?

On the DEPLOY registry, comparable biometric robots to Withings ScanWatch include Blackrock Neuroport Array, BrainQ Non-Invasive BCI, Neko Body Scan, RNS System.

How does Withings ScanWatch compare to Blackrock Neuroport Array?

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

Is Withings ScanWatch a top biometric?

On DEPLOY's intelligence score, which blends verified deployments, safety, adoption, media, and IP signals, Withings ScanWatch ranks in roughly the top 84% of biometric models tracked by the registry.

What is Withings ScanWatch's maturity stage?

Withings ScanWatch 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 Withings ScanWatch safe?

Withings ScanWatch has 1 active incident on record in the DEPLOY registry. 1 recall on record (1 moderate). Most recent: Dec 2022. Retracted incidents are excluded from this count.

Is the Withings ScanWatch FDA-cleared?

Yes. Withings received FDA clearance for the ScanWatch ECG and SpO2 monitoring features. The ScanWatch 2 offers on-demand SpO2 tracking, measuring blood oxygen levels in 30 seconds from the wrist. This can help detect respiratory disorders like COPD. Withings has 510(k) K201456.

Deployments

1 entry

Sectors & applications

1 entry