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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…

Track Withings ScanWatch
Manufacturer
Withings
Form factor
biometric
Maturity
commercial
Lifecycle
active
Deployments
1
Website
support.withings.com ↗

Overview

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.

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

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

FDA clearances

ECG app cleared Oct 2021 (K210580); ScanWatch 2 ECG cleared OTC July 2025; SpO2 FDA-cleared

Membership

Withings+ optional at $9.95/mo

Specs

Notes

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).

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: fda.gov 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

Data & sources

Press releases

3

Government records

1

Research

1

Web sources

2

7 sources backing this record.View all →

Availability and pricing

Availability
Shipping now
Price
$370 (actual sale price)as of 2026-06-17
Units in field
Not disclosed
Sales model
Not disclosed
Lead time
Not disclosed

Pricing

One-time purchase

$370 USDactual sale priceas of 2026-06-17

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 Jun 17, 2026

Deployments (1)

Withings ScanWatch on the deployment map

Where Withings ScanWatch 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 (1)

PRIMARY SOURCE
Courtesy of Withings

Withings' launch of the ScanWatch 2 and ScanWatch Light hybrid smartwatches. The ScanWatch line's FDA-cleared feature is its ECG (AFib detection); the original ScanWatch also carries an SpO2 clearance.

From deployment: Global

Regulatory filings (2)

Safety record

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

moderate
1

Most recent: Dec 2022

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

Incidents affecting Withings ScanWatch (1)

Includes incidents linked directly to this model or to deployments of it. Retracted incidents are excluded from this view but remain reachable at their canonical URLs.

Sources (7)

  1. https://en.wikipedia.org/wiki/Withings
  2. https://support.withings.com/hc/en-us/articles/16780197080209-ScanWatch-2-ECG-Frequently-Asked-Questions-FAQ-U-S-Only
  3. https://support.withings.com/hc/en-us/articles/36773695647249-ScanWatch-2-ECG-Update-2025-U-S
  4. https://sleepreviewmag.com/sleep-diagnostics/consumer-sleep-tracking/wearable-sleep-trackers/fda-clears-withings-scanwatch-spo2/
  5. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201456
  6. https://pmc.ncbi.nlm.nih.gov/articles/PMC8078374/
  7. https://www.withings.com/us/en/scanwatch-2

Compare Withings ScanWatch

Common questions

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.
Methodology: Verified · 7 sources (5 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
primary-company-ir
Company IR disclosure
1
knowledge-base
Knowledge base
1
unclassified
Unclassified source
1
primary-fda-database
FDA database
1
primary-academic-peer-reviewed
Peer-reviewed clinical / academic

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

Methodology surface for Withings ScanWatch.