Us2.v2

JSON twin: https://www.healthaidb.com/software/us2-v2.json

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

Categories

• clinical Care
• diagnostic Support
• cardiology
• imaging Software
• ai Clinical Documentation Integrity
• clinical Decision Support
• software Development
• healthcare Platform
• medical Device
• regulatory Compliance
• Clinical
• Diagnostic
• Imaging
• Ai
• Software
• Healthcare
• Fda-cleared
• Ce-marked

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.

Api Available

unknown

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

Company Founding

2017

Company Offices

• Singapore
• United States
• Canada
• Australia
• New Zealand
• United Kingdom
• Germany
• France
• India
• China

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

Customers

Data Residency

US/EU regions

Data Standards

• DICOM
• HL7
• FHIR

Deployment Model

• SaaS
• on_prem
• hybrid

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

Id

SW0238

Integration Partners

Integrations

• PACS
• Us2.connect server
• Viz.ai platform
• Aidoc's aiOS

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb
• consumer

Optional Modules

• Us2.connect server for enterprise-wide storage
• Mobile device with AI guidance plus CW/PW/Tissue Doppler and all 2D views

Os Platforms

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

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0238

Product Name

Us2.v2

Ratings

Regions Available

• United States
• Canada
• Australia
• New Zealand
• Singapore
• European Union
• 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

Security Features

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

Specialties

• Cardiology
• Echocardiography
• Heart Failure
• Cardiac Amyloidosis
• Pulmonary Hypertension
• Aortic Stenosis
• Heart Failure With Preserved Ejection Fraction

Support Channels

System Requirements

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

Target Users

• clinicians
• nurses
• patients
• admins
• payers

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "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"
  }
}