{"product_name":"Us2.v2","company_name":"Us2.ai","product_url":"https://us2.ai/us2-ai-receives-fda-clearance-for-us2-v2-transforming-cardiovascular-ultrasound-analysis/","company_url":"https://us2.ai","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0238","summary":"Us2.v2 is an FDA-cleared AI software that automates echocardiographic analysis, enhancing cardiovascular disease detection and management.","description":"Us2.v2 is an advanced image post-processing analysis software designed to aid diagnostic review, analysis, and reporting of echocardiographic DICOM images. It automatically generates clinically relevant and reproducible quantitative echocardiographic measurements, reducing analysis time and variability compared to human measurement. The software streamlines the echocardiographic workflow, enabling clinicians to generate and edit reports faster with precision and complete control. Key features include strain imaging, regional strain analysis, aortic stenosis measurements, and comprehensive quantitative analysis of cardiac structure and function. Us2.v2 is intended for use in adult patients and aims to support qualified cardiologists, sonographers, or other licensed healthcare practitioners in clinical decision-making processes.","categories":["clinical Care","diagnostic Support","cardiology","imaging Software","ai Clinical Documentation Integrity","clinical Decision Support","imaging Software","software Development","healthcare Platform","medical Device","regulatory Compliance","Clinical","Diagnostic","Cardiology","Imaging","Ai","Software","Healthcare","Medical Device","Fda-cleared","Ce-marked"],"market_segment":["enterprise","smb","consumer"],"target_users":["clinicians","nurses","patients","admins","payers"],"specialties":["Cardiology","Echocardiography","Heart Failure","Cardiac Amyloidosis","Pulmonary Hypertension","Aortic Stenosis","Heart Failure With Preserved Ejection Fraction"],"regions_available":["United States","Canada","Australia","New Zealand","Singapore","European Union","Mexico","Israel","Philippines","Brazil","Thailand","Taiwan","Indonesia","Vietnam","India"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["Singapore","United States","Canada","Australia","New Zealand","United Kingdom","Germany","France","India","China"],"company_founding":"2017","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Automated strain imaging with global longitudinal strain (GLS) quantification for heart failure detection","Regional strain analysis for coronary artery disease detection","Aortic stenosis measurements referencing ASE recommendations","Comprehensive quantitative analysis of cardiac structure and function, including left/right atrial and ventricular linear dimensions, volumes, systolic and diastolic function","Detection of cardiac amyloidosis and heart failure with preserved ejection fraction","Real-time fully automated image processing and analysis with reduced variability compared to human measurement","Explainable AI output allowing evaluation of all automated annotations and measurements","Automated generation of comprehensive reports","Integration of international guidelines into reports covering all heart chambers and both 2D and Doppler views","Decision support tools for qualified sonographers and reviewing physicians to edit and revise echocardiographic image measurements"],"optional_modules":["Us2.connect server for enterprise-wide storage","Mobile device with AI guidance plus CW/PW/Tissue Doppler and all 2D views"],"integrations":["PACS","Us2.connect server","Viz.ai platform","Aidoc's aiOS"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"unknown","system_requirements":"Major OS/DB/hardware needs, or empty if SaaS-only","compliance":["FDA 510(k)","CE Mark","Health Sciences Authority Singapore clearance","Regulatory clearances in Australia, New Zealand, Canada, United States, Singapore, European Union, Mexico, Israel, Philippines, Brazil, Thailand, Taiwan, Indonesia, Vietnam, India"],"certifications":["FDA 510(k)","CE Mark","Health Sciences Authority Singapore clearance","Regulatory clearances in Australia, New Zealand, Canada, United States, Singapore, European Union, Mexico, Israel, Philippines, Brazil, Thailand, Taiwan, Indonesia, Vietnam, India"],"security_features":["Encryption","RBAC","SSO/SAML","Audit logs","2FA","DLP"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0238","slug":"us2-v2","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/us2-v2.json"}}