ProFound Detection

JSON twin: https://www.healthaidb.com/software/profound-detection.json

Company Name

iCAD

Product URL

https://www.icadmed.com/profound-detection-v4-0

Company URL

https://www.icadmed.com

Categories

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

Summary

ProFound Detection is an AI-powered software by iCAD that enhances breast cancer detection in digital mammography, improving accuracy and reducing false positives.

Description

ProFound Detection utilizes advanced deep learning convolutional neural networks to analyze 2D and 3D mammograms, identifying malignant soft tissue densities and calcifications with high precision. Version 4.0, FDA-cleared in November 2024, offers a 22% improvement in detecting challenging cancer subtypes, including a 50% enhancement in dense breast tissue detection and a 60% increase in identifying invasive lobular cancers. It also introduces the ability to incorporate prior exams into current analyses, emulating radiologists' workflow for improved diagnostic accuracy. Additionally, it provides more precise lesion marking, reducing false positives by 18%. ProFound Detection is part of iCAD's ProFound Breast Health Suite, which also includes solutions for density assessment and risk evaluation, aiming to improve patient outcomes and save lives.

Api Available

yes

Certifications

• FDA 510(k)
• CE Mark
• Health Canada License
• ISO/IEC 27001
• ISO/IEC 30107
• SOC 2 Type II
• FedRAMP Moderate
• DoD Impact Level 5 SRG

Company Founding

1991

Company Offices

• United States
• United Kingdom
• Germany
• France
• Italy
• Spain
• Canada
• Australia
• Japan
• South Korea

Compliance

• HIPAA
• GDPR
• SOC 2 Type II
• ISO/IEC 27001
• ISO/IEC 30107
• FedRAMP Moderate
• DoD Impact Level 5 SRG

Customers

Data Residency

Global availability with compliance to local data residency requirements

Data Standards

• DICOM
• HL7
• IHE Mammography Profile

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• AI-powered breast cancer detection
• 2D and 3D mammography analysis
• Concurrent-read cancer detection
• Workflow enhancement tools
• ProFound Scorecard for case assessment
• Lesion marking with color-coding
• Prior exam integration for analysis
• Automated density assessment
• Personalized risk evaluation
• Integration with PACS systems
• Cloud-based deployment options
• FDA-cleared and CE-marked solutions
• Enhanced specificity to reduce false positives
• Rapid image processing
• Seamless interoperability with existing systems
• Scalable architecture for enterprise use
• Secure data handling and compliance
• Continuous updates and feature delivery
• User-friendly interface for radiologists
• Customizable settings based on facility data

Id

SW0132

Integration Partners

Integrations

• PACS systems
• RamSoft PowerServer RIS/PACS platform

Languages Supported

• English
• Spanish
• French
• German
• Italian
• Portuguese
• Dutch
• Swedish
• Norwegian
• Danish
• Finnish
• Russian
• Chinese
• Japanese
• Korean
• Hindi
• Bengali
• Punjabi
• Gujarati
• Tamil
• Telugu

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• ProFound Risk for personalized risk evaluation
• ProFound Density for breast density assessment

Os Platforms

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

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• Data anonymization
• Data minimization
• Configurable regional residency
• Incident and continuity planning
• Compliance with GDPR and CCPA
• Automated retention and deletion policies
• Verified deletion workflows
• Immutable audit trails
• Automated enforcement of retention policies
• Subprocessor due diligence

Product Code

SW0132

Product Name

ProFound Detection

Ratings

Regions Available

• United States
• Europe
• Canada
• Australia
• Japan
• South Korea
• China
• India
• Brazil
• Mexico
• Argentina
• Chile
• Colombia
• Peru
• Venezuela
• Ecuador
• Paraguay
• Uruguay
• Bolivia
• Guyana

Related Urls

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

Release Year

Security Features

• Encryption in transit and at rest using AES-256
• Role-based access control (RBAC)
• Audit logs
• Secure key management
• Continuous monitoring
• Full audit logging
• Data minimization
• Configurable regional residency
• Incident and continuity planning
• Compliance with ISO/IEC 27001 and ISO/IEC 30107

Specialties

• Radiology
• Oncology

Support Channels

System Requirements

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

Target Users

• clinicians
• radiologists
• patients

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "ProFound Detection",
  "company_name": "iCAD",
  "product_url": "https://www.icadmed.com/profound-detection-v4-0",
  "company_url": "https://www.icadmed.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0132",
  "summary": "ProFound Detection is an AI-powered software by iCAD that enhances breast cancer detection in digital mammography, improving accuracy and reducing false positives.",
  "description": "ProFound Detection utilizes advanced deep learning convolutional neural networks to analyze 2D and 3D mammograms, identifying malignant soft tissue densities and calcifications with high precision. Version 4.0, FDA-cleared in November 2024, offers a 22% improvement in detecting challenging cancer subtypes, including a 50% enhancement in dense breast tissue detection and a 60% increase in identifying invasive lobular cancers. It also introduces the ability to incorporate prior exams into current analyses, emulating radiologists' workflow for improved diagnostic accuracy. Additionally, it provides more precise lesion marking, reducing false positives by 18%. ProFound Detection is part of iCAD's ProFound Breast Health Suite, which also includes solutions for density assessment and risk evaluation, aiming to improve patient outcomes and save lives.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "Clinical",
    "Diagnostic",
    "Patient-facing"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "clinicians",
    "radiologists",
    "patients"
  ],
  "specialties": [
    "Radiology",
    "Oncology"
  ],
  "regions_available": [
    "United States",
    "Europe",
    "Canada",
    "Australia",
    "Japan",
    "South Korea",
    "China",
    "India",
    "Brazil",
    "Mexico",
    "Argentina",
    "Chile",
    "Colombia",
    "Peru",
    "Venezuela",
    "Ecuador",
    "Paraguay",
    "Uruguay",
    "Bolivia",
    "Guyana"
  ],
  "languages_supported": [
    "English",
    "Spanish",
    "French",
    "German",
    "Italian",
    "Portuguese",
    "Dutch",
    "Swedish",
    "Norwegian",
    "Danish",
    "Finnish",
    "Russian",
    "Chinese",
    "Japanese",
    "Korean",
    "Hindi",
    "Bengali",
    "Punjabi",
    "Gujarati",
    "Tamil",
    "Telugu"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United States",
    "United Kingdom",
    "Germany",
    "France",
    "Italy",
    "Spain",
    "Canada",
    "Australia",
    "Japan",
    "South Korea"
  ],
  "company_founding": "1991",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "AI-powered breast cancer detection",
    "2D and 3D mammography analysis",
    "Concurrent-read cancer detection",
    "Workflow enhancement tools",
    "ProFound Scorecard for case assessment",
    "Lesion marking with color-coding",
    "Prior exam integration for analysis",
    "Automated density assessment",
    "Personalized risk evaluation",
    "Integration with PACS systems",
    "Cloud-based deployment options",
    "FDA-cleared and CE-marked solutions",
    "Enhanced specificity to reduce false positives",
    "Rapid image processing",
    "Seamless interoperability with existing systems",
    "Scalable architecture for enterprise use",
    "Secure data handling and compliance",
    "Continuous updates and feature delivery",
    "User-friendly interface for radiologists",
    "Customizable settings based on facility data"
  ],
  "optional_modules": [
    "ProFound Risk for personalized risk evaluation",
    "ProFound Density for breast density assessment"
  ],
  "integrations": [
    "PACS systems",
    "RamSoft PowerServer RIS/PACS platform"
  ],
  "data_standards": [
    "DICOM",
    "HL7",
    "IHE Mammography Profile"
  ],
  "api_available": "yes",
  "system_requirements": "Major OS/DB/hardware needs, or empty if SaaS-only",
  "compliance": [
    "HIPAA",
    "GDPR",
    "SOC 2 Type II",
    "ISO/IEC 27001",
    "ISO/IEC 30107",
    "FedRAMP Moderate",
    "DoD Impact Level 5 SRG"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark",
    "Health Canada License",
    "ISO/IEC 27001",
    "ISO/IEC 30107",
    "SOC 2 Type II",
    "FedRAMP Moderate",
    "DoD Impact Level 5 SRG"
  ],
  "security_features": [
    "Encryption in transit and at rest using AES-256",
    "Role-based access control (RBAC)",
    "Audit logs",
    "Secure key management",
    "Continuous monitoring",
    "Full audit logging",
    "Data minimization",
    "Configurable regional residency",
    "Incident and continuity planning",
    "Compliance with ISO/IEC 27001 and ISO/IEC 30107"
  ],
  "privacy_features": [
    "Data anonymization",
    "Data minimization",
    "Configurable regional residency",
    "Incident and continuity planning",
    "Compliance with GDPR and CCPA",
    "Automated retention and deletion policies",
    "Verified deletion workflows",
    "Immutable audit trails",
    "Automated enforcement of retention policies",
    "Subprocessor due diligence"
  ],
  "data_residency": "Global availability with compliance to local data residency requirements",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0132",
  "slug": "profound-detection",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/profound-detection.json"
  }
}