Allix5

JSON twin: https://www.healthaidb.com/software/allix5.json

Company Name

Clairity

Product URL

https://clairity.com/allix5/

Company URL

https://clairity.com

Categories

• clinical Care
• diagnostic Support
• patient Facing
• Clinical
• Diagnostic

Summary

Allix5 is an AI-driven platform that predicts a woman's five-year breast cancer risk using routine screening mammograms, aiming to shift from reactive diagnosis to proactive prevention.

Description

Allix5, developed by Clairity, Inc., is the first FDA-authorized AI platform designed to predict a woman's five-year future risk of developing breast cancer based solely on a routine screening mammogram. It analyzes subtle imaging features to generate a personalized risk score, enabling clinicians to identify individuals at elevated risk and tailor follow-up care accordingly. The platform was trained on millions of mammogram images and validated across over 77,000 scans from diverse screening centers, ensuring broad applicability. Allix5 integrates seamlessly into existing clinical workflows, enhancing breast cancer risk assessment and prevention strategies.

Api Available

unknown

Certifications

• FDA 510(k)
• CE/MDR
• ONC
• ISO 27001
• ISO 27701
• SOC 2 Type II
• HIPAA
• SOC 1
• SOC 3
• FedRAMP
• UK NHS
• Australia IRAP
• SOCI
• GDPR
• ISO 27001:2022
• NIST 800-53
• PCI DSS
• FERPA
• CIS Critical Security Controls

Company Founding

2020

Company Offices

• United States

Compliance

• HIPAA
• GDPR
• HITECH
• SOC 2
• ISO 27001
• ISO 27701
• SOC 2 Type II
• NIST 800-53
• PCI DSS
• FERPA
• CIS Critical Security Controls
• SOC 1
• SOC 3
• FedRAMP
• UK NHS
• Australia IRAP
• SOCI
• ISO 27001:2022

Customers

Data Residency

US-only, with EU hosting planned

Data Standards

• FHIR
• HL7 v2
• DICOM
• SNOMED CT
• ICD-10
• LOINC
• CPT
• ICD-9
• NDC
• RxNorm

Deployment Model

• SaaS

Features

• Clinical documentation fax processing
• Natural Language Processing (NLP) data extraction
• Integration with Electronic Health Records (EHR)
• Automated data structuring
• Improved accuracy and efficiency in medical record handling
• Enhanced patient care through resource optimization
• Customizable solution for diverse healthcare needs
• Context-based understanding of medical documents
• Support for unstructured document formats
• Accelerated patient treatment workflows
• Optimized resource allocation across care continuum
• Improved healthcare interoperability
• Reduction of manual data entry errors
• Streamlined communication between healthcare providers
• Enhanced data accessibility and usability
• Support for various document types
• Real-time data processing
• Secure handling of sensitive patient information
• Compliance with healthcare data privacy regulations
• Scalable solution for healthcare organizations

Id

SW0006

Integration Partners

Integrations

• Electronic Health Records (EHR) systems
• Medical imaging systems
• Laboratory Information Management Systems (LIMS)
• Patient management systems
• Billing and coding systems
• Clinical decision support systems
• Health information exchanges (HIE)
• Patient portals
• Telemedicine platforms
• Pharmacy management systems
• Radiology information systems (RIS)
• Clinical trial management systems (CTMS)
• Health data analytics platforms
• Medical device interfaces
• Appointment scheduling systems
• Patient monitoring systems
• Clinical research databases
• Health insurance claim systems
• Medical transcription services
• Clinical data repositories

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• consumer

Optional Modules

• Advanced analytics dashboard
• Integration with additional EHR systems
• Customizable reporting tools
• Automated compliance reporting
• Data visualization tools
• Patient engagement features
• Mobile access support
• Multi-language support
• Audit trail functionality
• Role-based access control

Os Platforms

• Web

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization
• Data residency options
• Data subject access requests
• Data processing agreements
• Privacy impact assessments
• Third-party sub-processors
• External audit reports

Product Code

SW0006

Product Name

Allix5

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

• Encryption
• RBAC
• SSO/SAML
• Audit logs
• 2FA
• DLP
• Vulnerability scanning
• Penetration testing
• Access controls
• Data masking

Specialties

• Radiology
• Oncology

Support Channels

System Requirements

Target Users

• clinicians
• patients

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Allix5",
  "company_name": "Clairity",
  "product_url": "https://clairity.com/allix5/",
  "company_url": "https://clairity.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0006",
  "summary": "Allix5 is an AI-driven platform that predicts a woman's five-year breast cancer risk using routine screening mammograms, aiming to shift from reactive diagnosis to proactive prevention.",
  "description": "Allix5, developed by Clairity, Inc., is the first FDA-authorized AI platform designed to predict a woman's five-year future risk of developing breast cancer based solely on a routine screening mammogram. It analyzes subtle imaging features to generate a personalized risk score, enabling clinicians to identify individuals at elevated risk and tailor follow-up care accordingly. The platform was trained on millions of mammogram images and validated across over 77,000 scans from diverse screening centers, ensuring broad applicability. Allix5 integrates seamlessly into existing clinical workflows, enhancing breast cancer risk assessment and prevention strategies.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "Clinical",
    "Diagnostic",
    "Patient-facing"
  ],
  "market_segment": [
    "enterprise",
    "consumer"
  ],
  "target_users": [
    "clinicians",
    "patients"
  ],
  "specialties": [
    "Radiology",
    "Oncology"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2020",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "Clinical documentation fax processing",
    "Natural Language Processing (NLP) data extraction",
    "Integration with Electronic Health Records (EHR)",
    "Automated data structuring",
    "Improved accuracy and efficiency in medical record handling",
    "Enhanced patient care through resource optimization",
    "Customizable solution for diverse healthcare needs",
    "Context-based understanding of medical documents",
    "Support for unstructured document formats",
    "Accelerated patient treatment workflows",
    "Optimized resource allocation across care continuum",
    "Improved healthcare interoperability",
    "Reduction of manual data entry errors",
    "Streamlined communication between healthcare providers",
    "Enhanced data accessibility and usability",
    "Support for various document types",
    "Real-time data processing",
    "Secure handling of sensitive patient information",
    "Compliance with healthcare data privacy regulations",
    "Scalable solution for healthcare organizations"
  ],
  "optional_modules": [
    "Advanced analytics dashboard",
    "Integration with additional EHR systems",
    "Customizable reporting tools",
    "Automated compliance reporting",
    "Data visualization tools",
    "Patient engagement features",
    "Mobile access support",
    "Multi-language support",
    "Audit trail functionality",
    "Role-based access control"
  ],
  "integrations": [
    "Electronic Health Records (EHR) systems",
    "Medical imaging systems",
    "Laboratory Information Management Systems (LIMS)",
    "Patient management systems",
    "Billing and coding systems",
    "Clinical decision support systems",
    "Health information exchanges (HIE)",
    "Patient portals",
    "Telemedicine platforms",
    "Pharmacy management systems",
    "Radiology information systems (RIS)",
    "Clinical trial management systems (CTMS)",
    "Health data analytics platforms",
    "Medical device interfaces",
    "Appointment scheduling systems",
    "Patient monitoring systems",
    "Clinical research databases",
    "Health insurance claim systems",
    "Medical transcription services",
    "Clinical data repositories"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED CT",
    "ICD-10",
    "LOINC",
    "CPT",
    "ICD-9",
    "NDC",
    "RxNorm"
  ],
  "api_available": "unknown",
  "system_requirements": "",
  "compliance": [
    "HIPAA",
    "GDPR",
    "HITECH",
    "SOC 2",
    "ISO 27001",
    "ISO 27701",
    "SOC 2 Type II",
    "NIST 800-53",
    "PCI DSS",
    "FERPA",
    "CIS Critical Security Controls",
    "SOC 1",
    "SOC 3",
    "FedRAMP",
    "UK NHS",
    "Australia IRAP",
    "SOCI",
    "ISO 27001:2022"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE/MDR",
    "ONC",
    "ISO 27001",
    "ISO 27701",
    "SOC 2 Type II",
    "HIPAA",
    "SOC 1",
    "SOC 3",
    "FedRAMP",
    "UK NHS",
    "Australia IRAP",
    "SOCI",
    "GDPR",
    "ISO 27001:2022",
    "NIST 800-53",
    "PCI DSS",
    "FERPA",
    "CIS Critical Security Controls"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit logs",
    "2FA",
    "DLP",
    "Vulnerability scanning",
    "Penetration testing",
    "Access controls",
    "Data masking"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization",
    "Data residency options",
    "Data subject access requests",
    "Data processing agreements",
    "Privacy impact assessments",
    "Third-party sub-processors",
    "External audit reports"
  ],
  "data_residency": "US-only, with EU hosting planned",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0006",
  "slug": "allix5",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/allix5.json"
  }
}