{"product_name":"Genius AI Detection 2.0","company_name":"Hologic","product_url":"https://www.hologic.com/geniusai-detection-part2","company_url":"https://www.hologic.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0141","summary":"Genius AI Detection 2.0 is an AI-powered mammography software by Hologic that enhances breast cancer detection accuracy and streamlines radiologist workflows.","description":"Genius AI Detection 2.0 utilizes deep learning to identify potential breast cancers in digital breast tomosynthesis images with high sensitivity. It offers features like automated lesion correlation, reduced false-positive markings, and integration with SecurView 12.0 software for efficient case prioritization. The solution is FDA-cleared and has demonstrated consistent performance across diverse patient populations.","categories":["clinical Care","diagnostic Support","radiology","imaging Software","ai Clinical Documentation Integrity","clinical Decision Support","imaging Software","clinical Workflow Automation","breast Imaging","Clinical","Diagnostic","Radiology","Imaging","Ai","Workflow","Breast Health"],"market_segment":["enterprise","smb"],"target_users":["radiologists","clinicians","medical imaging professionals"],"specialties":["Radiology","Oncology","Breast Imaging"],"regions_available":["United States","Europe","Asia","Australia","Canada","Latin America","Middle East","Africa"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Dutch","Japanese","Chinese","Korean","Arabic","Russian","Turkish","Hindi","Bengali","Punjabi","Telugu","Marathi","Tamil","Urdu"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United States","United Kingdom","Germany","France","Italy","Spain","Australia","Japan","China","India"],"company_founding":"1985","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Deep learning-based analysis of digital breast tomosynthesis (DBT) images","Identification and marking of suspicious soft tissue densities and calcifications","Provision of confidence scores for each lesion and overall case","Automated lesion correlation between CC and MLO views","Integration with Hologic's Selenia Dimensions and Envision Mammography Platforms","Point-of-care triaging with immediate access to results on acquisition workstation","Case Score indicating confidence in malignancy","Case Complexity Index categorizing cases based on suspicious markings","Reading Priority Indicator flagging most concerning cases during the exam","Read Time Indicator estimating expected reading time for radiologists","High sensitivity of 94% for breast cancer detection","Over 70% reduction in false positive markings per case compared to previous CAD systems","Integration with SecurView 12.0 software for patient worklist management","Support for 3DQuorum SmartSlices and synthesized 2D images","Compatibility with multiple mammography platforms","Real-time analysis and display of results during the exam","Enhanced workflow efficiency for radiologists","Clinical decision support tools to aid in patient management","Continuous updates and improvements based on AI advancements"],"optional_modules":["Automated lesion correlation feature","Advanced workflow tools","Clinical decision support tools"],"integrations":["Selenia Dimensions","Envision Mammography Platform","SecurView 12.0 software","3DQuorum SmartSlices","Synthesized 2D images"],"data_standards":["DICOM Mammography CAD SR","DICOM","HL7","FHIR"],"api_available":"unknown","system_requirements":"Compatible with Hologic's Selenia Dimensions and Envision Mammography Platforms","compliance":["FDA 510(k) clearance","HIPAA","ISO 27001","SOC 2","GDPR","HITECH","SOC 1","SOC 3","ISO 9001","ISO 13485","ISO 14971","IEC 62304","IEC 62366","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-8","IEC 60601-1-11","IEC 60601-1-12","IEC 60601-1-15","IEC 60601-1-16"],"certifications":["FDA 510(k) clearance","CE Mark","ISO 13485","ISO 9001","ISO 14971","IEC 62304","IEC 62366","IEC 60601-1","IEC 60601-1-2","IEC 60601-1-6","IEC 60601-1-8","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"],"security_features":["Encryption","RBAC","SSO/SAML","Audit logs","2FA","DLP"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0141","slug":"genius-ai-detection-2-0","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/genius-ai-detection-2-0.json"}}