{"product_name":"Scan Monitor 2.0","company_name":"Withings","product_url":"https://www.withings.com/en-us/scan-monitor-2-0","company_url":"https://www.withings.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"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":["diagnostic Support","patient Facing","clinical Care","remote Monitoring","Diagnostic","Patient-facing","Clinical","Health Monitoring"],"market_segment":["consumer","enterprise"],"target_users":["patients","health-conscious individuals","clinicians","healthcare professionals"],"specialties":["Cardiology","General Health Monitoring"],"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"],"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":{"self":"https://www.healthaidb.com/software/scan-monitor-2-0.json"}}