FFRangio System

JSON twin: https://www.healthaidb.com/software/ffrangio-system.json

Company Name

CathWorks

Product URL

https://cath.works/cathworks-ffrangio/

Company URL

https://cath.works

Categories

• clinical Care
• diagnostic Support
• cardiology
• imaging Software
• ai Clinical Documentation Integrity
• clinical Decision Support
• medical Device
• clinical Assessment Tools
• Clinical
• Diagnostic
• Medical Imaging
• Artificial Intelligence
• Non-invasive
• Cardiovascular Disease
• Angiography
• Physiological Assessment

Summary

The FFRangio System by CathWorks is a non-invasive, AI-driven tool that provides real-time physiological assessments of coronary artery disease using routine angiograms, eliminating the need for pressure wires and drug stimulation.

Description

The FFRangio System combines artificial intelligence and advanced computational science to obtain physiological information from routine angiograms, offering quick and reliable intraprocedural assessments of the entire coronary tree. It eliminates the need for invasive pressure wires, drugs, or guide catheters, reducing radiation exposure by approximately 20% compared to wire-based physiology. The system features an intuitive user interface, AI-assisted angiogram analysis, and seamless integration with cath lab equipment and PACS. It provides real-time FFRangio values at every point along the coronary tree, a simulated pullback curve to differentiate functional patterns of CAD, and an integrated sizing tool for non-invasive lesion measurements. The system has demonstrated high diagnostic accuracy and promising outcomes, with similar major adverse cardiovascular event rates at one year compared to wire-based FFR. It has received FDA 510(k) clearance and is approved under the European Union Medical Device Regulation (MDR) 2017/745. The fourth-generation application has been approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

Api Available

unknown

Certifications

• FDA 510(k)
• CE/MDR
• ONC
• ISO

Company Founding

2012

Company Offices

• United States
• Israel
• Japan
• Germany
• France
• United Kingdom
• India
• China
• South Korea
• Brazil

Compliance

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

Customers

Data Residency

US/EU regions

Data Standards

• FHIR
• HL7 v2
• DICOM

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Non-invasive FFR guidance
• 3D coronary tree reconstruction
• Real-time FFR values
• Simulated pullback curve
• Lesion Impact assessment
• Integrated sizing tool
• Intuitive user interface
• AI-assisted angiogram analysis
• Functional assessment during angiography
• Seamless integration with boom and PACS

Id

SW0569

Integration Partners

Integrations

• Boom
• PACS

Languages Supported

• English
• Japanese
• German
• French
• Spanish
• Italian
• Dutch
• Portuguese
• Russian
• Chinese
• Arabic
• Hindi
• Bengali
• Punjabi
• Javanese
• Korean
• Vietnamese
• Telugu
• Marathi
• Turkish

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• Lesion Impact feature

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

Enterprise_Quote

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0569

Product Name

FFRangio System

Ratings

Regions Available

• United States
• Europe
• Japan
• Asia
• Middle East

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
• Interventional Cardiology
• Medical Imaging
• Vascular Medicine
• Cardiovascular Surgery
• Radiology
• Emergency Medicine
• Internal Medicine
• Geriatrics
• Family Medicine
• Preventive Medicine
• Sports Medicine
• Pediatrics
• Obstetrics And Gynecology
• Endocrinology
• Nephrology
• Pulmonology
• Hematology
• Oncology
• Rheumatology

Support Channels

System Requirements

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

Target Users

• Clinicians
• Cardiologists
• Interventional Cardiologists
• Medical Imaging Technologists
• Hospital Administrators

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "FFRangio System",
  "company_name": "CathWorks",
  "product_url": "https://cath.works/cathworks-ffrangio/",
  "company_url": "https://cath.works",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0569",
  "summary": "The FFRangio System by CathWorks is a non-invasive, AI-driven tool that provides real-time physiological assessments of coronary artery disease using routine angiograms, eliminating the need for pressure wires and drug stimulation.",
  "description": "The FFRangio System combines artificial intelligence and advanced computational science to obtain physiological information from routine angiograms, offering quick and reliable intraprocedural assessments of the entire coronary tree. It eliminates the need for invasive pressure wires, drugs, or guide catheters, reducing radiation exposure by approximately 20% compared to wire-based physiology. The system features an intuitive user interface, AI-assisted angiogram analysis, and seamless integration with cath lab equipment and PACS. It provides real-time FFRangio values at every point along the coronary tree, a simulated pullback curve to differentiate functional patterns of CAD, and an integrated sizing tool for non-invasive lesion measurements. The system has demonstrated high diagnostic accuracy and promising outcomes, with similar major adverse cardiovascular event rates at one year compared to wire-based FFR. It has received FDA 510(k) clearance and is approved under the European Union Medical Device Regulation (MDR) 2017/745. The fourth-generation application has been approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).",
  "categories": [
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    "diagnostic Support",
    "cardiology",
    "imaging Software",
    "ai Clinical Documentation Integrity",
    "clinical Decision Support",
    "medical Device",
    "clinical Assessment Tools",
    "Clinical",
    "Diagnostic",
    "Cardiology",
    "Medical Imaging",
    "Artificial Intelligence",
    "Medical Device",
    "Non-invasive",
    "Cardiovascular Disease",
    "Angiography",
    "Physiological Assessment"
  ],
  "market_segment": [
    "Enterprise",
    "SMB"
  ],
  "target_users": [
    "Clinicians",
    "Cardiologists",
    "Interventional Cardiologists",
    "Medical Imaging Technologists",
    "Hospital Administrators"
  ],
  "specialties": [
    "Cardiology",
    "Interventional Cardiology",
    "Medical Imaging",
    "Vascular Medicine",
    "Cardiovascular Surgery",
    "Radiology",
    "Emergency Medicine",
    "Internal Medicine",
    "Geriatrics",
    "Family Medicine",
    "Preventive Medicine",
    "Sports Medicine",
    "Pediatrics",
    "Obstetrics And Gynecology",
    "Endocrinology",
    "Nephrology",
    "Pulmonology",
    "Hematology",
    "Oncology",
    "Rheumatology"
  ],
  "regions_available": [
    "United States",
    "Europe",
    "Japan",
    "Asia",
    "Middle East"
  ],
  "languages_supported": [
    "English",
    "Japanese",
    "German",
    "French",
    "Spanish",
    "Italian",
    "Dutch",
    "Portuguese",
    "Russian",
    "Chinese",
    "Arabic",
    "Hindi",
    "Bengali",
    "Punjabi",
    "Javanese",
    "Korean",
    "Vietnamese",
    "Telugu",
    "Marathi",
    "Turkish"
  ],
  "pricing_model": "Enterprise_Quote",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "United States",
    "Israel",
    "Japan",
    "Germany",
    "France",
    "United Kingdom",
    "India",
    "China",
    "South Korea",
    "Brazil"
  ],
  "company_founding": "2012",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "Non-invasive FFR guidance",
    "3D coronary tree reconstruction",
    "Real-time FFR values",
    "Simulated pullback curve",
    "Lesion Impact assessment",
    "Integrated sizing tool",
    "Intuitive user interface",
    "AI-assisted angiogram analysis",
    "Functional assessment during angiography",
    "Seamless integration with boom and PACS"
  ],
  "optional_modules": [
    "Lesion Impact feature"
  ],
  "integrations": [
    "Boom",
    "PACS"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM"
  ],
  "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/MDR",
    "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": "",
  "integration_partners": [],
  "id": "SW0569",
  "slug": "ffrangio-system",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/ffrangio-system.json"
  }
}