Withings Scan Monitor

by Withings  · Based in France → — We create technology that people love, to make better health part of daily life.
Cardiology Internal Medicine

Device purchase with optional subscription for enhanced features and clinical services.
Regulatory Status Disclosed

Overview

Withings Scan Monitor is an AI-powered health monitoring tool integrated into Withings’ smart devices, such as the Body Scan connected health station and ScanWatch hybrid smartwatches. It provides medical-grade data for cardiovascular health assessment and remote patient monitoring. The Scan Monitor enables users and healthcare professionals to record electrocardiograms (ECG) for the detection of atrial fibrillation (AFib) and measure heart rate. When integrated into the Body Scan, it offers a 6-lead ECG, vascular age assessment, nerve health score, and segmental body composition analysis. In the ScanWatch, it provides a single-lead ECG and measures blood oxygen saturation (SpO2). Data is automatically synchronized to the Withings Health Mate mobile app, allowing for detailed insights, trend tracking, and easy sharing with clinicians.

Withings Health Solutions offers a comprehensive remote patient monitoring (RPM) platform for healthcare providers, integrating these devices to facilitate continuous access to patient health data, streamline billing for CPT codes, and enhance patient engagement through an AI-powered digital assistant.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • 6-lead ECG for Atrial Fibrillation (AFib) detection (Body Scan)
  • Single-lead ECG for Atrial Fibrillation (AFib) detection (ScanWatch)
  • Heart rate measurement and irregular rhythm notifications
  • Blood oxygen saturation (SpO2) measurement (ScanWatch)
  • Vascular Age assessment (Body Scan)
  • Nerve Health Score (Electrodermal Activity) (Body Scan)
  • Segmental body composition analysis (Body Scan)
  • Automatic data synchronization via Wi-Fi and Bluetooth
  • Companion mobile application (Withings Health Mate app)
  • Multi-user recognition (up to 8 users for Body Scan)

Use Cases

  • Remote patient monitoring (RPM) for chronic disease management
  • Early detection and ongoing monitoring of Atrial Fibrillation (AFib)
  • Comprehensive cardiovascular health assessment and management
  • Weight management and detailed body composition tracking
  • Sleep pattern analysis and detection of breathing disturbances (ScanWatch)
  • General wellness and preventive health insights for patients

What Physicians Need to Know

ECG/EKG Analysis Capability
The Withings Scan Monitor records a single-channel ECG (similar to lead I) and the Scan Monitor 2.0, when combined with the Withings Body Scan, records a 6-lead ECG. It detects the presence of Atrial Fibrillation (AFib) and sinus rhythm, calculating heart rate, P wave duration, PR interval, QT interval, QT corrected interval, and QRS duration. Results are classified as Sinus Rhythm, Atrial Fibrillation, or Inconclusive. Clinical-ready PDF reports can be generated for physician review.
Arrhythmia Detection Accuracy
The Scan Monitor software demonstrated 98.16% sensitivity in classifying AFib and 97.20% specificity in classifying sinus rhythm in classifiable recordings from public databases. In clinical validation studies, the ScanWatch (incorporating Scan Monitor) showed 96.3% sensitivity for AFib and 100% specificity for normal sinus rhythm on conclusive recordings, with approximately 19.5% of recordings being inconclusive. Another study reported 76% sensitivity and 99% specificity for AFib detection using the automated algorithm, with cardiologist interpretation of iECGs from the device achieving 98% diagnostic accuracy. The device can identify up to 10 arrhythmias, primarily focusing on AFib, but cannot detect arrhythmias other than AFib.
Cardiac Monitoring Integration
Data is transferred to the Withings app (Health Mate app) via Bluetooth LE. Withings offers a 'Cardio Check-Up' service (with a Withings+ subscription) where board-certified cardiologists review ECG data and other health information within 24 hours. Withings Remote Patient Monitoring (RPM) integrates with various EHR platforms for seamless data synchronization, device ordering, billing, and alerts. It also provides Public API, Cellular Integration, and SDK Integration for developers, and integrates with platforms like Fitrockr and Validic.
AHA/ACC Guideline Alignment
The Withings Scan Monitor (and ScanWatch) is FDA-cleared. Its clinical validation studies compare its performance against a 12-lead ECG, considered the industry gold standard. The software's accuracy in classifying ECG recordings was tested according to the IEC 60601-2-47 standard.
Physician Tip

The Withings Scan Monitor, particularly the ScanWatch models, offers a convenient tool for patients to monitor their heart rhythm and detect potential Atrial Fibrillation (AFib) at home. While it provides valuable single-lead (or 6-lead with Body Scan) ECG data and automated AFib detection, clinicians should be aware of its limitations, including a percentage of inconclusive readings and its inability to detect arrhythmias other than AFib or ischemic heart conditions. The 'Cardio Check-Up' service, offering cardiologist review of ECGs, can be a useful adjunct for interpreting ambiguous readings or identifying other potential cardiac irregularities. Encourage patients to share PDF reports of their ECGs for comprehensive review. The device serves as a screening tool and should not replace traditional diagnostic methods or professional medical advice.

Withings devices, including the Scan Monitor, integrate seamlessly with the Withings Health Mate app for data visualization and management. For healthcare providers, Withings offers Remote Patient Monitoring (RPM) solutions with integration capabilities for Electronic Health Record (EHR) platforms, facilitating data synchronization and alert management. Developers can leverage Public API, Cellular Integration, and SDK Integration options to incorporate Withings health data into other applications and systems. Compatibility with third-party platforms like Fitrockr and Validic further enhances its utility in broader health ecosystems. The ability to connect with IFTTT also allows for custom automation workflows.

Details

Category Cardiology AI, Wearables & Remote Monitoring (RPM)
Pricing Device purchase with optional subscription for enhanced features and clinical services.
  • Body Scan device: ~$400-$500
  • Withings+ subscription: ~$9.95/month (includes features like Cardio Check-Up reviews)
DeploymentDevice-based (smart scale, smartwatch) with cloud synchronization and mobile application.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Withings Scan Monitor 2.0, integrated into the Body Scan, received 510(k) clearance (K230812) on August 23, 2023, for detecting atrial fibrillation using a 6-lead ECG. The original Withings Scan Monitor (version 1.0) for ScanWatch received FDA clearance on October 12, 2021, for AFib detection via a single-lead ECG and SpO2 measurements.

Integrations
EHR Not specified
Specialties Cardiology, Internal Medicine

What the Web Says

The Withings Scan Monitor, encompassing devices like the ScanWatch and Body Scan, generally receives positive feedback for its elegant design, comprehensive health tracking features, and impressive battery life. Physicians and tech reviewers often highlight its medical-grade sensors and the ability to monitor various vital signs. However, some users report issues with accuracy in certain metrics and the accompanying app's usability.

Overall: Mixed

Strengths

  • Elegant and traditional watch design (ScanWatch).
  • Comprehensive health monitoring (ECG, SpO2, heart rate, temperature, sleep, body composition).
  • Long battery life (up to 30-35 days for ScanWatch).
  • Clinically validated technology for some features.
  • Useful for remote patient monitoring and televisits (BeamO).
  • Good for tracking general health trends and consistency over time.

Limitations

  • Inaccurate sleep, activity, and workout tracking reported by some users.
  • Bluetooth connection issues and limited range.
  • Crown button functionality issues on some ScanWatch models.
  • App can be disorganized, confusing, or buggy.
  • Body composition accuracy may not be precise enough for athletes.
  • High price point and potential for subscription fees for advanced features.

Based on reviews from: Reddit, The Guardian, Pocketables, Withings Official Site, PCMag, Trustpilot, Sleepopolis, Best Buy, Men's Journal, Live Science, RedditRecs

Last updated: 2026-07-19

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Press & Coverage

Withings S.A. / International Weighing Review
Withings Announces FDA Clearance of its Highly Anticipated Body Scan Health Station
Withings announced FDA clearance for its Body Scan Connected Health Station, which uses Withings Scan Monitor 2.0 to detect atrial fibrillation via a 6-lead ECG. The device will be available in the US for $399.95 and offers daily analysis of biomarkers and advanced smart scale capabilities.
2023-08
MedTech Dive
Withings wins FDA clearance for scale with AFib detection
Withings received FDA 510(k) clearance for its Body Scan Connected Health Station, referred to as Withings Scan Monitor 2.0 when the ECG function is active, enabling it to detect atrial fibrillation using a 6-lead ECG. This clearance allows Withings to launch the smart scale in the U.S., expanding on its existing Body Scan sales in other regions.
2023-08
HLTH
Withings' Body Scan Connected Health Station cleared by FDA - HLTH
Withings' Body Scan Connected Health Station, powered by Withings Scan Monitor 2.0, has received FDA clearance for detecting atrial fibrillation using a 6-lead ECG. This device provides daily assessments of biomarkers and monitors segmental body composition, heart rate, and vascular age.
2023-08
accessdata.fda.gov
510(k) Premarket Notification - FDA
This FDA 510(k) Premarket Notification details the clearance for Withings Scan Monitor 2.0, identifying Withings as the applicant. The device is classified under regulation number 870.234023 with product code DPS24.
2023-08
accessdata.fda.gov
August 23, 2023 Withings Khushboo Surendran Regulatory Affairs Manager 2 rue Maurice Hartmann Issy-Les-Moulineaux, Ile-De-France - accessdata.fda.gov
The FDA's letter to Withings confirms the clearance of Withings Scan Monitor 2.0, intended to record, store, and transfer two-channel ECG data and detect atrial fibrillation. It is for use by healthcare professionals and individuals in various settings.
2023-08
PR Newswire
Withings BodyScan 2 Now Available in the US, Setting a Standard in Preventive Health and Longevity Monitoring
Withings BodyScan 2, featuring the FDA-cleared Withings Scan Monitor 2.0 software for ECG and AFib detection, is now available in the US for $599.95. This health station offers comprehensive cardiac, vascular, and metabolic analysis, along with longevity insights.
2026-07
JB Hi-Fi
Withings Scanwatch Nova Brilliant Edition (Silver) - JB Hi-Fi
The Withings ScanWatch Nova, a luxury diver-style watch, offers advanced health tracking including on-demand medical-grade electrocardiogram via Withings Scan Monitor, SpO2, and continuous body temperature monitoring. The Scan Monitor functionality will be rolled out in a future update.
2023-12
Journal of Medical Internet Research
Validation of the Withings ScanWatch as a Wrist-Worn Reflective Pulse Oximeter: Prospective Interventional Clinical Study - PMC
This clinical study validated the accuracy of the Withings ScanWatch's reflective pulse oximeter function, powered by the Withings Scan Monitor software, for measuring SpO2 levels. The study confirmed its clinical-grade accuracy and safety during mild, moderate, and severe hypoxia.
2021-04

Videos

Product demos, reviews, and walkthroughs for Withings Scan Monitor.

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Frequently Asked Questions

The Withings Scan Monitor, particularly with devices like the Body Scan and ScanWatch 2, uses AI to analyze various health metrics such as 6-lead ECG for AFib detection, segmental body composition, vascular age, and nerve activity. Through the Withings+ subscription, AI-powered insights offer personalized health advice, smart trends, and a Vitality Indicator to help users and physicians track and improve health outcomes.
The Withings Scan Monitor 2.0, integrated into the Body Scan, has received FDA clearance for detecting atrial fibrillation using its 6-lead ECG technology, making it the first health station to achieve this. The Scan Monitor 1.0, used in the ScanWatch, also has FDA clearance for 1-lead ECG and SpO2 measurements for AFib detection.
A notable limitation is the occurrence of inconclusive ECG recordings, which can be as high as 20.2% for the Scan Monitor and 19.5% for the ScanWatch 2 in clinical settings. The devices are not continuous AFib monitors and may not detect all instances of AFib, with heart rate measurements on the ScanWatch occurring every 10 minutes, potentially missing short-term changes.
The Withings Body Scan device is priced around $399.95 to $499.95, and accessing its full AI-powered features and advanced insights typically requires a Withings+ subscription, which costs approximately $9.95 per month or $99.50 annually. Withings also offers remote patient monitoring solutions for healthcare professionals, which can support CPT code billing.
Alternatives for remote patient monitoring include platforms like Xealth, Biofourmis Care, Validic Impact, and Rimidi's Disease Management Platform, which offer comprehensive solutions for clinicians. For personal health tracking, devices such as the Apple Watch, WHOOP, and Oura Ring also provide various health insights, though their medical clearances and specific features may differ.
Withings offers remote patient monitoring solutions designed to integrate health data, allowing for transparent access to patient metrics and the potential for automatic upload of RPM service charges into EHR systems. This aims to streamline claim creation and provide audit reports for compliance.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19

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