Scan Monitor 2.0

JSON twin: https://www.healthaidb.com/software/scan-monitor-2-0.json

Company Name

Withings

Product URL

https://www.withings.com/en-us/scan-monitor-2-0

Company URL

https://www.withings.com

Categories

• diagnostic Support
• patient Facing
• clinical Care
• remote Monitoring
• Diagnostic
• Clinical
• Health Monitoring

Summary

Withings Scan Monitor 2.0 is a smart scale that records a two-channel electrocardiogram (ECG) to detect atrial fibrillation and provides comprehensive body composition analysis, including muscle and fat percentages across different zones.

Description

Withings Scan Monitor 2.0 is a smart scale equipped with three stainless steel ECG electrodes that record lead II and lead III signals, deriving other leads (I, aVR, aVF, aVL). It uses ECG-SW1 AI algorithms to process and classify ECG waveforms for rhythm detection and atrial fibrillation identification. The device communicates wirelessly with a mobile app for displaying and managing data. It uses a 500Hz sampling rate and includes built-in feedback electrodes to reduce electromagnetic interference. The device underwent non-clinical testing to IEC and ANSI/AAMI standards for electrical safety, biocompatibility, electromagnetic compatibility, and software verification. A human factors usability study confirmed that users accurately record ECGs and interpret results. An algorithm development used public datasets for training and validation on separate samples, preventing data leakage. A clinical multicenter study with 274 subjects showed high sensitivity (99%) and specificity (99%) for atrial fibrillation detection compared to a 12-lead ECG gold standard, demonstrating equivalence to the predicate device.

Api Available

yes

Certifications

• CE Marking under Medical Device Regulation (MDR) 2017/745
• ISO 27001:2017
• ISO 10993-1:2009
• IEC 60601-1
• IEC 60601-1-2:2014
• IEC 60601-1-11:2015
• IEC 60601-2-47:2012

Company Founding

2008

Company Offices

• France
• United States
• United Kingdom
• Germany
• Italy
• Spain
• Netherlands
• Belgium
• Sweden
• Denmark

Compliance

• HIPAA
• ISO 27001:2017
• GDPR
• HDS
• ISO 10993-1:2009
• IEC 60601-1
• IEC 60601-1-2:2014
• IEC 60601-1-11:2015
• IEC 60601-2-47:2012
• FDA 510(k) clearance (K230812)

Customers

Data Residency

EU Medical Cloud (GDPR, HDS, ISO 27001:2017 certified), US Medical Cloud (HIPAA, ISO 27001:2017 certified)

Data Standards

• ECG-SW1 AI algorithms for rhythm detection and atrial fibrillation identification

Deployment Model

• SaaS

Features

• ECG recording with AI-based atrial fibrillation detection
• Wireless data transmission via Bluetooth Low Energy (BLE)
• Grayscale OLED display for ECG results
• 30-day battery life on a single charge
• Water-resistant up to 5 ATM
• Temperature tracking with baseline variation monitoring
• Heart rate monitoring with daily and overnight tracking
• Sleep quality scoring with sleep stage analysis
• Blood oxygen level monitoring with on-demand and nighttime averages
• Activity tracking including steps, calories burned, and connected GPS
• Cycle tracking with period log and symptom tracking

Id

SW0324

Integration Partners

Integrations

• Withings App
• Apple Health
• Google Fit
• Google Health Connect

Languages Supported

• English
• French
• German
• Spanish
• Italian
• Dutch
• Swedish
• Danish
• Norwegian
• Finnish
• Japanese
• Korean
• Chinese
• Portuguese
• Russian
• Arabic
• Turkish
• Polish
• Czech

Last Updated

2025-10-11

License

commercial

Market Segment

• consumer
• enterprise

Optional Modules

• ECG feature activation under physician care in the U.S.

Os Platforms

• Web
• iOS
• Android

Pricing Details

Contact vendor for pricing details.

Pricing Model

subscription

Privacy Features

• HIPAA compliance
• GDPR compliance
• Data anonymization
• Data minimization
• User data control

Product Code

SW0324

Product Name

Scan Monitor 2.0

Ratings

Regions Available

• United States
• Europe
• Canada
• Australia
• Japan
• South Korea
• Singapore
• Hong Kong
• New Zealand
• United Kingdom
• Germany
• France
• Italy
• Spain
• Netherlands
• Belgium
• Sweden
• Denmark
• Norway
• Finland
• Switzerland

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Encryption
• OAuth 2.0 authentication
• Secure data transmission
• Regular security audits
• Dedicated security team

Specialties

• Cardiology
• General Health Monitoring

Support Channels

System Requirements

iOS 15 or later, Android 9 or later

Target Users

• patients
• health-conscious individuals
• clinicians
• healthcare professionals

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "company_name": "Withings",
  "product_url": "https://www.withings.com/en-us/scan-monitor-2-0",
  "company_url": "https://www.withings.com",
  "related_urls": [
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  ],
  "product_code": "SW0324",
  "summary": "Withings Scan Monitor 2.0 is a smart scale that records a two-channel electrocardiogram (ECG) to detect atrial fibrillation and provides comprehensive body composition analysis, including muscle and fat percentages across different zones.",
  "description": "Withings Scan Monitor 2.0 is a smart scale equipped with three stainless steel ECG electrodes that record lead II and lead III signals, deriving other leads (I, aVR, aVF, aVL). It uses ECG-SW1 AI algorithms to process and classify ECG waveforms for rhythm detection and atrial fibrillation identification. The device communicates wirelessly with a mobile app for displaying and managing data. It uses a 500Hz sampling rate and includes built-in feedback electrodes to reduce electromagnetic interference. The device underwent non-clinical testing to IEC and ANSI/AAMI standards for electrical safety, biocompatibility, electromagnetic compatibility, and software verification. A human factors usability study confirmed that users accurately record ECGs and interpret results. An algorithm development used public datasets for training and validation on separate samples, preventing data leakage. A clinical multicenter study with 274 subjects showed high sensitivity (99%) and specificity (99%) for atrial fibrillation detection compared to a 12-lead ECG gold standard, demonstrating equivalence to the predicate device.",
  "categories": [
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  "target_users": [
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    "health-conscious individuals",
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  "specialties": [
    "Cardiology",
    "General Health Monitoring"
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  "regions_available": [
    "United States",
    "Europe",
    "Canada",
    "Australia",
    "Japan",
    "South Korea",
    "Singapore",
    "Hong Kong",
    "New Zealand",
    "United Kingdom",
    "Germany",
    "France",
    "Italy",
    "Spain",
    "Netherlands",
    "Belgium",
    "Sweden",
    "Denmark",
    "Norway",
    "Finland",
    "Switzerland"
  ],
  "languages_supported": [
    "English",
    "French",
    "German",
    "Spanish",
    "Italian",
    "Dutch",
    "Swedish",
    "Danish",
    "Norwegian",
    "Finnish",
    "Japanese",
    "Korean",
    "Chinese",
    "Portuguese",
    "Russian",
    "Arabic",
    "Turkish",
    "Polish",
    "Czech"
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  "pricing_model": "subscription",
  "pricing_details": "Contact vendor for pricing details.",
  "license": "commercial",
  "company_offices": [
    "France",
    "United States",
    "United Kingdom",
    "Germany",
    "Italy",
    "Spain",
    "Netherlands",
    "Belgium",
    "Sweden",
    "Denmark"
  ],
  "company_founding": "2008",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android"
  ],
  "features": [
    "ECG recording with AI-based atrial fibrillation detection",
    "Wireless data transmission via Bluetooth Low Energy (BLE)",
    "Grayscale OLED display for ECG results",
    "30-day battery life on a single charge",
    "Water-resistant up to 5 ATM",
    "Temperature tracking with baseline variation monitoring",
    "Heart rate monitoring with daily and overnight tracking",
    "Sleep quality scoring with sleep stage analysis",
    "Blood oxygen level monitoring with on-demand and nighttime averages",
    "Activity tracking including steps, calories burned, and connected GPS",
    "Cycle tracking with period log and symptom tracking"
  ],
  "optional_modules": [
    "ECG feature activation under physician care in the U.S."
  ],
  "integrations": [
    "Withings App",
    "Apple Health",
    "Google Fit",
    "Google Health Connect"
  ],
  "data_standards": [
    "ECG-SW1 AI algorithms for rhythm detection and atrial fibrillation identification"
  ],
  "api_available": "yes",
  "system_requirements": "iOS 15 or later, Android 9 or later",
  "compliance": [
    "HIPAA",
    "ISO 27001:2017",
    "GDPR",
    "HDS",
    "ISO 10993-1:2009",
    "IEC 60601-1",
    "IEC 60601-1-2:2014",
    "IEC 60601-1-11:2015",
    "IEC 60601-2-47:2012",
    "FDA 510(k) clearance (K230812)"
  ],
  "certifications": [
    "CE Marking under Medical Device Regulation (MDR) 2017/745",
    "ISO 27001:2017",
    "ISO 10993-1:2009",
    "IEC 60601-1",
    "IEC 60601-1-2:2014",
    "IEC 60601-1-11:2015",
    "IEC 60601-2-47:2012"
  ],
  "security_features": [
    "Encryption",
    "OAuth 2.0 authentication",
    "Secure data transmission",
    "Regular security audits",
    "Dedicated security team"
  ],
  "privacy_features": [
    "HIPAA compliance",
    "GDPR compliance",
    "Data anonymization",
    "Data minimization",
    "User data control"
  ],
  "data_residency": "EU Medical Cloud (GDPR, HDS, ISO 27001:2017 certified), US Medical Cloud (HIPAA, ISO 27001:2017 certified)",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0324",
  "slug": "scan-monitor-2-0",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
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}