Us2.v1

JSON twin: https://www.healthaidb.com/software/us2-v1.json

Company Name

Us2.ai

Product URL

https://us2.ai/product

Company URL

https://us2.ai

Categories

• clinical Care
• diagnostic Support
• imaging Software
• cardiology
• clinical Decision Support
• ai Clinical Documentation Integrity
• Clinical
• Diagnostic
• Imaging
• Decision Support
• Machine Learning

Summary

Us2.v1 is an AI-driven software that automates the analysis of transthoracic echocardiography, providing comprehensive cardiac measurements and reports to support clinicians in diagnosing heart diseases.

Description

Us2.v1 is an FDA-cleared and CE-marked automated clinical workflow solution developed by Us2.ai. It processes 2D, M-mode, and Doppler echocardiographic images to deliver complete, editable reports with measurements and annotations for all four heart chambers. The software integrates with existing PACS systems and adheres to international guidelines, enhancing diagnostic efficiency and accuracy in cardiovascular care.

Api Available

unknown

Certifications

• FDA 510(k)
• CE Mark
• ONC
• ISO

Company Founding

2017

Company Offices

• Singapore

Compliance

• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001

Customers

Data Residency

US/EU regions

Data Standards

• DICOM
• ASE guidelines
• EACVI guidelines

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Automated 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 analyses with reduced variability compared to human measurement
• Disease detection capabilities for heart failure, cardiac amyloidosis, pulmonary hypertension, and aortic stenosis
• Standardized echo reads for retrospective, prospective, and longitudinal surveillance with zero variability
• Full suite of measurements at population health level scale
• Fully automated echo reports compatible with mobile devices featuring AI guidance, CW/PW/Tissue Doppler, and all 2D views

Id

SW0459

Integration Partners

Integrations

• PACS solutions
• Us2.connect server

Languages Supported

• English

Last Updated

2025-10-11

License

commercial proprietary

Market Segment

• enterprise
• provider
• hospital
• point-of-care

Optional Modules

• Us2.connect server for enterprise-wide storage

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

Subscription pricing; typically tiered based on number of analyses — contact vendor for commercial pricing and trial info

Pricing Model

subscription

Privacy Features

• BAA available
• consent management
• anonymization
• data minimization

Product Code

SW0459

Product Name

Us2.v1

Ratings

Regions Available

• United States
• European Union
• Canada
• Australia
• New Zealand
• Singapore
• Mexico
• Israel
• Philippines
• Brazil
• Thailand
• Taiwan
• Indonesia
• Vietnam
• India

Related Urls

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

Release Year

2025

Security Features

• Encryption
• RBAC
• SSO/SAML
• audit logs
• 2FA
• DLP

Specialties

• Cardiology
• Echocardiography
• Cardiac Imaging
• Heart Failure
• Pulmonology

Support Channels

System Requirements

Major OS/DB/hardware needs, or empty if SaaS-only

Target Users

• cardiologists
• echocardiography sonographers
• cardiac imaging specialists
• radiologists
• clinical administrators

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Us2.v1",
  "company_name": "Us2.ai",
  "product_url": "https://us2.ai/product",
  "company_url": "https://us2.ai",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0459",
  "summary": "Us2.v1 is an AI-driven software that automates the analysis of transthoracic echocardiography, providing comprehensive cardiac measurements and reports to support clinicians in diagnosing heart diseases.",
  "description": "Us2.v1 is an FDA-cleared and CE-marked automated clinical workflow solution developed by Us2.ai. It processes 2D, M-mode, and Doppler echocardiographic images to deliver complete, editable reports with measurements and annotations for all four heart chambers. The software integrates with existing PACS systems and adheres to international guidelines, enhancing diagnostic efficiency and accuracy in cardiovascular care.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "imaging Software",
    "cardiology",
    "clinical Decision Support",
    "ai Clinical Documentation Integrity",
    "clinical Decision Support",
    "Clinical",
    "Diagnostic",
    "Imaging",
    "Cardiology",
    "Decision Support",
    "Machine Learning"
  ],
  "market_segment": [
    "enterprise",
    "provider",
    "hospital",
    "point-of-care"
  ],
  "target_users": [
    "cardiologists",
    "echocardiography sonographers",
    "cardiac imaging specialists",
    "radiologists",
    "clinical administrators"
  ],
  "specialties": [
    "Cardiology",
    "Echocardiography",
    "Cardiac Imaging",
    "Heart Failure",
    "Pulmonology"
  ],
  "regions_available": [
    "United States",
    "European Union",
    "Canada",
    "Australia",
    "New Zealand",
    "Singapore",
    "Mexico",
    "Israel",
    "Philippines",
    "Brazil",
    "Thailand",
    "Taiwan",
    "Indonesia",
    "Vietnam",
    "India"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Subscription pricing; typically tiered based on number of analyses — contact vendor for commercial pricing and trial info",
  "license": "commercial proprietary",
  "company_offices": [
    "Singapore"
  ],
  "company_founding": "2017",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Automated 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 analyses with reduced variability compared to human measurement",
    "Disease detection capabilities for heart failure, cardiac amyloidosis, pulmonary hypertension, and aortic stenosis",
    "Standardized echo reads for retrospective, prospective, and longitudinal surveillance with zero variability",
    "Full suite of measurements at population health level scale",
    "Fully automated echo reports compatible with mobile devices featuring AI guidance, CW/PW/Tissue Doppler, and all 2D views"
  ],
  "optional_modules": [
    "Us2.connect server for enterprise-wide storage"
  ],
  "integrations": [
    "PACS solutions",
    "Us2.connect server"
  ],
  "data_standards": [
    "DICOM",
    "ASE guidelines",
    "EACVI guidelines"
  ],
  "api_available": "unknown",
  "system_requirements": "Major OS/DB/hardware needs, or empty if SaaS-only",
  "compliance": [
    "HIPAA",
    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark",
    "ONC",
    "ISO"
  ],
  "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": "2025",
  "integration_partners": [],
  "id": "SW0459",
  "slug": "us2-v1",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/us2-v1.json"
  }
}