{"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"}}