Transpara Breast AI

JSON twin: https://www.healthaidb.com/software/transpara-breast-ai.json

Company Name

ScreenPoint Medical

Product URL

https://screenpoint-medical.com/transpara

Company URL

https://screenpoint-medical.com

Categories

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

Summary

Transpara Breast AI is an FDA-cleared and CE-marked artificial intelligence system designed to assist radiologists in detecting breast cancer earlier and reducing recall rates by analyzing 2D and 3D mammography exams.

Description

Transpara Breast AI, developed by ScreenPoint Medical, integrates into existing radiology workflows to enhance the detection of breast cancer. It analyzes mammography images, highlights suspicious regions, and assigns risk scores to prioritize cases. The system is FDA-cleared and CE-marked for use with 2D and 3D mammography from multiple manufacturers, including Hologic, GE, Siemens, Fuji, and Philips. Transpara has been implemented in over 30 countries, supporting both population screening and diagnostic workflows. Clinical studies have demonstrated its effectiveness in improving detection rates and reducing reading times for radiologists. Additionally, Transpara has been integrated into major medical centers, such as Johns Hopkins, to further enhance cancer detection capabilities. The system is continuously updated to incorporate the latest advancements in artificial intelligence and machine learning, ensuring optimal performance in breast cancer screening and diagnostics.

Api Available

yes

Certifications

• FDA 510(k) K241831
• CE mark (0344)

Company Founding

2014

Company Offices

• Netherlands
• United States
• Germany
• United Kingdom
• France
• Italy
• Spain
• Sweden
• Denmark
• Norway

Compliance

• HIPAA
• GDPR
• CE (EU medical device)
• FDA 510(k) cleared

Customers

Data Residency

US and EU hosting options; on-prem deployments for customer region control

Data Standards

• DICOM
• HL7 v2
• FHIR
• SNOMED
• ICD-10

Deployment Model

• on_prem
• cloud
• hybrid

Features

• AI detection and marking of suspicious lesions on 2D FFDM and 3D DBT
• Exam-level cancer risk/triage score
• Lesion-level heatmaps and overlays in reader hanging protocols
• Automated density assessment (Transpara Density)
• Prioritization/triage of worklists to surface high-risk studies
• Integration into existing PACS viewer context (no separate UI)
• Reader-specific configurable scoring/hanging preferences
• Batch processing and background analysis of mammography exams
• Quality assurance metrics and performance monitoring
• Clinical decision support for screening workflows
• Support for both screening and diagnostic mammography workflows
• Study-level reporting flags/annotations ingestible by RIS/PACS

Id

SW0123

Integration Partners

Integrations

• PACS (generic DICOM PACS vendors)
• Sectra
• Ikonopedia
• Aidoc
• Agfa
• GE Healthcare
• Fujifilm
• LifeVoxel
• RIS
• EMR/EHR (Epic, Cerner)

Languages Supported

• English
• Spanish
• French
• German
• Italian
• Dutch
• Portuguese
• Russian
• Chinese
• Japanese
• Korean
• Arabic
• Hindi
• Bengali
• Punjabi
• Telugu
• Marathi
• Tamil
• Urdu
• Gujarati
• Malayalam

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• Transpara Density (breast density assessment)
• DBT/tomosynthesis advanced support
• Enterprise integration connectors (PACS/RIS/EHR adapters)
• Analytics/reporting module
• Cloud-managed deployment/managed service

Os Platforms

• Web
• Windows
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• Business Associate Agreement (BAA) available
• Patient data anonymization/deidentification options
• Data minimization controls
• Consent management support (via integrations)

Product Code

SW0123

Product Name

Transpara Breast AI

Ratings

Regions Available

• United States
• Europe
• Asia
• Australia
• Canada
• South America
• Africa
• Middle East
• India
• China
• Japan
• South Korea
• Singapore
• Malaysia
• Thailand
• Indonesia
• Philippines
• Vietnam
• Pakistan
• Bangladesh
• Sri Lanka

Related Urls

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

Release Year

Security Features

• TLS encrypted transport
• Role-based access control (RBAC)
• Audit logging
• SSO/SAML support
• Two-factor authentication (2FA)

Specialties

• Radiology
• Oncology
• Medical Imaging

Support Channels

System Requirements

On-prem virtual appliance or server; Intel x86 CPU; NVIDIA GPU support for acceleration; Linux VM supported; DICOM-compatible PACS and network connectivity

Target Users

• radiologists
• clinicians
• medical imaging professionals

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Transpara Breast AI",
  "company_name": "ScreenPoint Medical",
  "product_url": "https://screenpoint-medical.com/transpara",
  "company_url": "https://screenpoint-medical.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0123",
  "summary": "Transpara Breast AI is an FDA-cleared and CE-marked artificial intelligence system designed to assist radiologists in detecting breast cancer earlier and reducing recall rates by analyzing 2D and 3D mammography exams.",
  "description": "Transpara Breast AI, developed by ScreenPoint Medical, integrates into existing radiology workflows to enhance the detection of breast cancer. It analyzes mammography images, highlights suspicious regions, and assigns risk scores to prioritize cases. The system is FDA-cleared and CE-marked for use with 2D and 3D mammography from multiple manufacturers, including Hologic, GE, Siemens, Fuji, and Philips. Transpara has been implemented in over 30 countries, supporting both population screening and diagnostic workflows. Clinical studies have demonstrated its effectiveness in improving detection rates and reducing reading times for radiologists. Additionally, Transpara has been integrated into major medical centers, such as Johns Hopkins, to further enhance cancer detection capabilities. The system is continuously updated to incorporate the latest advancements in artificial intelligence and machine learning, ensuring optimal performance in breast cancer screening and diagnostics.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "administrative Operations",
    "Clinical",
    "Diagnostic",
    "Administrative"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "radiologists",
    "clinicians",
    "medical imaging professionals"
  ],
  "specialties": [
    "Radiology",
    "Oncology",
    "Medical Imaging"
  ],
  "regions_available": [
    "United States",
    "Europe",
    "Asia",
    "Australia",
    "Canada",
    "South America",
    "Africa",
    "Middle East",
    "India",
    "China",
    "Japan",
    "South Korea",
    "Singapore",
    "Malaysia",
    "Thailand",
    "Indonesia",
    "Philippines",
    "Vietnam",
    "Pakistan",
    "Bangladesh",
    "Sri Lanka"
  ],
  "languages_supported": [
    "English",
    "Spanish",
    "French",
    "German",
    "Italian",
    "Dutch",
    "Portuguese",
    "Russian",
    "Chinese",
    "Japanese",
    "Korean",
    "Arabic",
    "Hindi",
    "Bengali",
    "Punjabi",
    "Telugu",
    "Marathi",
    "Tamil",
    "Urdu",
    "Gujarati",
    "Malayalam"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "Netherlands",
    "United States",
    "Germany",
    "United Kingdom",
    "France",
    "Italy",
    "Spain",
    "Sweden",
    "Denmark",
    "Norway"
  ],
  "company_founding": "2014",
  "deployment_model": [
    "on_prem",
    "cloud",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "Windows",
    "Linux"
  ],
  "features": [
    "AI detection and marking of suspicious lesions on 2D FFDM and 3D DBT",
    "Exam-level cancer risk/triage score",
    "Lesion-level heatmaps and overlays in reader hanging protocols",
    "Automated density assessment (Transpara Density)",
    "Prioritization/triage of worklists to surface high-risk studies",
    "Integration into existing PACS viewer context (no separate UI)",
    "Reader-specific configurable scoring/hanging preferences",
    "Batch processing and background analysis of mammography exams",
    "Quality assurance metrics and performance monitoring",
    "Clinical decision support for screening workflows",
    "Support for both screening and diagnostic mammography workflows",
    "Study-level reporting flags/annotations ingestible by RIS/PACS"
  ],
  "optional_modules": [
    "Transpara Density (breast density assessment)",
    "DBT/tomosynthesis advanced support",
    "Enterprise integration connectors (PACS/RIS/EHR adapters)",
    "Analytics/reporting module",
    "Cloud-managed deployment/managed service"
  ],
  "integrations": [
    "PACS (generic DICOM PACS vendors)",
    "Sectra",
    "Ikonopedia",
    "Aidoc",
    "Agfa",
    "GE Healthcare",
    "Fujifilm",
    "LifeVoxel",
    "RIS",
    "EMR/EHR (Epic, Cerner)"
  ],
  "data_standards": [
    "DICOM",
    "HL7 v2",
    "FHIR",
    "SNOMED",
    "ICD-10"
  ],
  "api_available": "yes",
  "system_requirements": "On-prem virtual appliance or server; Intel x86 CPU; NVIDIA GPU support for acceleration; Linux VM supported; DICOM-compatible PACS and network connectivity",
  "compliance": [
    "HIPAA",
    "GDPR",
    "CE (EU medical device)",
    "FDA 510(k) cleared"
  ],
  "certifications": [
    "FDA 510(k) K241831",
    "CE mark (0344)"
  ],
  "security_features": [
    "TLS encrypted transport",
    "Role-based access control (RBAC)",
    "Audit logging",
    "SSO/SAML support",
    "Two-factor authentication (2FA)"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA) available",
    "Patient data anonymization/deidentification options",
    "Data minimization controls",
    "Consent management support (via integrations)"
  ],
  "data_residency": "US and EU hosting options; on-prem deployments for customer region control",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0123",
  "slug": "transpara-breast-ai",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/transpara-breast-ai.json"
  }
}