{"product_name":"SmartMammo Density","company_name":"DeepHealth","product_url":"https://deephealth.com/population-health/smart-mammo/","company_url":"https://deephealth.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0110","summary":"SmartMammo Density is an AI-powered solution by DeepHealth that enhances breast cancer detection accuracy and workflow efficiency by integrating with existing mammography systems.","description":"SmartMammo Density utilizes AI to improve the detection of breast cancer by providing automatic lesion localization, assessing the degree of suspicion, and classifying tissue density. It integrates seamlessly with existing mammography systems, enhancing diagnostic accuracy and operational efficiency. The solution has been FDA-cleared for use with GE HealthCare’s Senographe Pristina™ and Hologic’s digital breast tomosynthesis (DBT) systems, demonstrating its versatility across different imaging platforms. SmartMammo Density has been shown to increase cancer detection rates by 21% in DBT and 9.4% in 2D mammography, with additional benefits in detecting cancers in women with dense breasts and Black/African American women. It also reduces missed cancers by 45.8% and improves workflow efficiency with instant image streaming and AI-powered alerts for prioritizing exam reviews.","categories":["clinical Care","diagnostic Support","imaging Software","ai Clinical Documentation Integrity","clinical Workflow Optimization","Clinical","Diagnostic","Imaging","Ai-powered","Workflow Enhancement"],"market_segment":["enterprise","smb"],"target_users":["radiologists","clinicians","medical imaging professionals"],"specialties":["Radiology","Oncology","Breast Imaging"],"regions_available":["United States","Europe","Asia","Australia","Canada","South America","Africa","Middle East","India","China"],"languages_supported":["English","Spanish","French","German","Italian","Portuguese","Dutch","Russian","Chinese","Japanese"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["United States","United Kingdom","Germany","France","India","China","Japan","Australia","Canada","Brazil"],"company_founding":"2018","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web"],"features":["AI-powered breast density assessment","Automatic lesion localization","Degree of suspicion scoring","Tissue density scoring","Integration with existing mammography systems","Enhanced diagnostic accuracy","Improved workflow efficiency","Real-time image streaming","Intelligent worklist sorting","Smart alerts for exam prioritization"],"optional_modules":["SmartMammo Dx","DeepHealth Viewer","SmartMammo Assure"],"integrations":["GE HealthCare Senographe Pristina","Hologic mammography systems"],"data_standards":["DICOM","HL7 v2"],"api_available":"unknown","system_requirements":"","compliance":["HIPAA","FDA 510(k) clearance"],"certifications":["FDA 510(k) clearance"],"security_features":["Data encryption","Role-based access control","Audit logs"],"privacy_features":["Data anonymization","Consent management"],"data_residency":"United States, Canada, United Kingdom","customers":["RadNet/BRMG","Delaware Imaging Network, RadNet","New York Imaging Network, RadNet"],"user_reviews":["It has made me considerably more efficient due to decreased lag between loading patient studies, in particular as it relates to breast tomography where I can instantly review the current study along with multiple prior exams.","SmartMammo™ helps me read smarter and more efficiently. It allows me to sort and prioritize mammograms most likely to have cancer in them and draws my attention to what really matters in each image."],"ratings":["9.4% Increase CDR in DM (2D)","21% Increase CDR in DBT (3D)","21% Increase CDR in SmartMammo™","23% More cancers detected in women with dense breasts","20% More cancers detected in Black/African American women"],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2020","integration_partners":["RadNet","Delaware Imaging Network","New York Imaging Network"],"id":"SW0110","slug":"smartmammo-density","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/smartmammo-density.json"}}