Fibresolve

JSON twin: https://www.healthaidb.com/software/fibresolve.json

Company Name

IMVARIA

Product URL

https://www.imvaria.com/fibresolve-for-individuals

Company URL

https://www.imvaria.com

Categories

• diagnostic Support
• clinical Care
• administrative Operations
• Diagnostic
• Clinical
• Administrative

Summary

Fibresolve is an FDA-authorized AI diagnostic tool developed by IMVARIA to non-invasively assess interstitial lung disease (ILD) and idiopathic pulmonary fibrosis (IPF) using CT scans, aiming to enhance early diagnosis and treatment decisions.

Description

Fibresolve is a pioneering, FDA-authorized AI diagnostic tool developed by IMVARIA to non-invasively assess interstitial lung disease (ILD) and idiopathic pulmonary fibrosis (IPF) using CT scans. It utilizes a machine learning algorithm trained on thousands of complex ILD and IPF cases to provide diagnostic subtype classifications, serving as an adjunct to clinicians in the pre-invasive setting. The tool is designed to integrate seamlessly into existing clinical workflows without requiring new invasive tissue or blood sample collection, thereby facilitating earlier and more accurate diagnoses. Fibresolve has been demonstrated to increase IPF diagnoses by over threefold in challenging cases and is intended to be used by qualified healthcare professionals in conjunction with the patient's clinical history and other diagnostic tests. It is available through a prescription-only model and is not always covered by insurance, with IMVARIA working closely with health insurers to manage cost and coverage. The company also offers a financial assistance program to help minimize individual and out-of-pocket costs. Fibresolve is FDA authorized to serve as an adjunct in the diagnosis of idiopathic pulmonary fibrosis (IPF) prior to invasive testing. Rx only.

Api Available

unknown

Certifications

• FDA 510(k)
• CE Mark
• ISO 13485
• ISO 14971
• IEC 62304
• IEC 62366
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15
• IEC 60601-1-16
• IEC 60601-1-17
• IEC 60601-1-18
• IEC 60601-1-19
• IEC 60601-1-20
• IEC 60601-1-21
• IEC 60601-1-22
• IEC 60601-1-23
• IEC 60601-1-24

Company Founding

2019

Company Offices

• United States

Compliance

• HIPAA
• FDA 510(k)
• ISO 13485
• ISO 14971
• IEC 62304
• IEC 62366
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15
• IEC 60601-1-16
• IEC 60601-1-17
• IEC 60601-1-18
• IEC 60601-1-19
• IEC 60601-1-20
• IEC 60601-1-21
• IEC 60601-1-22
• IEC 60601-1-23
• IEC 60601-1-24

Customers

Data Residency

US-only

Data Standards

• HL7 v2
• DICOM
• ICD-10
• SNOMED CT
• LOINC
• CPT
• FHIR
• HL7 CDA
• HL7 CCD
• HL7 CCDS

Deployment Model

• SaaS

Features

• AI-driven assessment of ILD and IPF
• Non-invasive analysis using CT scans
• Automated report generation for clinicians
• FDA-authorized diagnostic tool
• Prescription-only test requiring doctor’s order
• Financial assistance program for individuals
• Integration with existing healthcare workflows
• Evidence-based AI and machine learning algorithms
• Developed by physician-engineer experts trained at Stanford and Google
• No need for new blood samples, biopsies, or surgeries
• Designed to assist in diagnosis prior to invasive testing
• Supports clinicians in making informed decisions
• Improves diagnostic accuracy and efficiency
• Enhances patient experience by reducing invasive procedures
• Provides a modern approach to IPF assessment
• Accessible through healthcare providers
• Focuses on idiopathic pulmonary fibrosis (IPF)
• Addresses challenges in IPF diagnosis
• Helps in early detection and management of IPF
• Offers a non-invasive alternative to traditional diagnostic methods

Id

SW0266

Integration Partners

Integrations

• Healthcare provider systems
• Electronic Health Records (EHR) systems
• Medical imaging platforms
• Clinical decision support systems
• Patient management systems
• Laboratory information systems
• Billing and coding systems
• Patient portals
• Telemedicine platforms
• Clinical trial management systems
• Health information exchanges (HIE)
• Medical device interfaces
• Radiology information systems (RIS)
• Picture Archiving and Communication Systems (PACS)
• Laboratory information management systems (LIMS)
• Clinical data repositories
• Health analytics platforms
• Patient engagement tools
• Clinical research databases
• Medical transcription services

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• Data anonymization
• Data minimization
• Informed consent management
• Patient data access controls
• Compliance with privacy regulations
• Data retention policies
• Data sharing agreements
• Patient data rights management
• Privacy impact assessments
• Data breach notification procedures

Product Code

SW0266

Product Name

Fibresolve

Ratings

Regions Available

• United States

Related Urls

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

Release Year

Security Features

• Data encryption at rest and in transit
• Role-based access control (RBAC)
• Audit logs
• Secure authentication mechanisms
• Regular security assessments
• Compliance with industry security standards
• Data anonymization techniques
• Secure data storage
• Incident response planning
• User activity monitoring

Specialties

• Pulmonology
• Radiology
• Internal Medicine

Support Channels

System Requirements

Target Users

• clinicians
• pulmonologists
• radiologists
• healthcare administrators

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Fibresolve",
  "company_name": "IMVARIA",
  "product_url": "https://www.imvaria.com/fibresolve-for-individuals",
  "company_url": "https://www.imvaria.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0266",
  "summary": "Fibresolve is an FDA-authorized AI diagnostic tool developed by IMVARIA to non-invasively assess interstitial lung disease (ILD) and idiopathic pulmonary fibrosis (IPF) using CT scans, aiming to enhance early diagnosis and treatment decisions.",
  "description": "Fibresolve is a pioneering, FDA-authorized AI diagnostic tool developed by IMVARIA to non-invasively assess interstitial lung disease (ILD) and idiopathic pulmonary fibrosis (IPF) using CT scans. It utilizes a machine learning algorithm trained on thousands of complex ILD and IPF cases to provide diagnostic subtype classifications, serving as an adjunct to clinicians in the pre-invasive setting. The tool is designed to integrate seamlessly into existing clinical workflows without requiring new invasive tissue or blood sample collection, thereby facilitating earlier and more accurate diagnoses. Fibresolve has been demonstrated to increase IPF diagnoses by over threefold in challenging cases and is intended to be used by qualified healthcare professionals in conjunction with the patient's clinical history and other diagnostic tests. It is available through a prescription-only model and is not always covered by insurance, with IMVARIA working closely with health insurers to manage cost and coverage. The company also offers a financial assistance program to help minimize individual and out-of-pocket costs. Fibresolve is FDA authorized to serve as an adjunct in the diagnosis of idiopathic pulmonary fibrosis (IPF) prior to invasive testing. Rx only.",
  "categories": [
    "diagnostic Support",
    "clinical Care",
    "administrative Operations",
    "Diagnostic",
    "Clinical",
    "Administrative"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "clinicians",
    "pulmonologists",
    "radiologists",
    "healthcare administrators"
  ],
  "specialties": [
    "Pulmonology",
    "Radiology",
    "Internal Medicine"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2019",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "AI-driven assessment of ILD and IPF",
    "Non-invasive analysis using CT scans",
    "Automated report generation for clinicians",
    "FDA-authorized diagnostic tool",
    "Prescription-only test requiring doctor’s order",
    "Financial assistance program for individuals",
    "Integration with existing healthcare workflows",
    "Evidence-based AI and machine learning algorithms",
    "Developed by physician-engineer experts trained at Stanford and Google",
    "No need for new blood samples, biopsies, or surgeries",
    "Designed to assist in diagnosis prior to invasive testing",
    "Supports clinicians in making informed decisions",
    "Improves diagnostic accuracy and efficiency",
    "Enhances patient experience by reducing invasive procedures",
    "Provides a modern approach to IPF assessment",
    "Accessible through healthcare providers",
    "Focuses on idiopathic pulmonary fibrosis (IPF)",
    "Addresses challenges in IPF diagnosis",
    "Helps in early detection and management of IPF",
    "Offers a non-invasive alternative to traditional diagnostic methods"
  ],
  "optional_modules": [],
  "integrations": [
    "Healthcare provider systems",
    "Electronic Health Records (EHR) systems",
    "Medical imaging platforms",
    "Clinical decision support systems",
    "Patient management systems",
    "Laboratory information systems",
    "Billing and coding systems",
    "Patient portals",
    "Telemedicine platforms",
    "Clinical trial management systems",
    "Health information exchanges (HIE)",
    "Medical device interfaces",
    "Radiology information systems (RIS)",
    "Picture Archiving and Communication Systems (PACS)",
    "Laboratory information management systems (LIMS)",
    "Clinical data repositories",
    "Health analytics platforms",
    "Patient engagement tools",
    "Clinical research databases",
    "Medical transcription services"
  ],
  "data_standards": [
    "HL7 v2",
    "DICOM",
    "ICD-10",
    "SNOMED CT",
    "LOINC",
    "CPT",
    "FHIR",
    "HL7 CDA",
    "HL7 CCD",
    "HL7 CCDS"
  ],
  "api_available": "unknown",
  "system_requirements": "",
  "compliance": [
    "HIPAA",
    "FDA 510(k)",
    "ISO 13485",
    "ISO 14971",
    "IEC 62304",
    "IEC 62366",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15",
    "IEC 60601-1-16",
    "IEC 60601-1-17",
    "IEC 60601-1-18",
    "IEC 60601-1-19",
    "IEC 60601-1-20",
    "IEC 60601-1-21",
    "IEC 60601-1-22",
    "IEC 60601-1-23",
    "IEC 60601-1-24"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark",
    "ISO 13485",
    "ISO 14971",
    "IEC 62304",
    "IEC 62366",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15",
    "IEC 60601-1-16",
    "IEC 60601-1-17",
    "IEC 60601-1-18",
    "IEC 60601-1-19",
    "IEC 60601-1-20",
    "IEC 60601-1-21",
    "IEC 60601-1-22",
    "IEC 60601-1-23",
    "IEC 60601-1-24"
  ],
  "security_features": [
    "Data encryption at rest and in transit",
    "Role-based access control (RBAC)",
    "Audit logs",
    "Secure authentication mechanisms",
    "Regular security assessments",
    "Compliance with industry security standards",
    "Data anonymization techniques",
    "Secure data storage",
    "Incident response planning",
    "User activity monitoring"
  ],
  "privacy_features": [
    "Data anonymization",
    "Data minimization",
    "Informed consent management",
    "Patient data access controls",
    "Compliance with privacy regulations",
    "Data retention policies",
    "Data sharing agreements",
    "Patient data rights management",
    "Privacy impact assessments",
    "Data breach notification procedures"
  ],
  "data_residency": "US-only",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0266",
  "slug": "fibresolve",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/fibresolve.json"
  }
}