{"product_name":"DM-Density","company_name":"Densitas","product_url":"https://densitashealth.com/dm-density","company_url":"https://densitashealth.com","related_urls":["https://www.auntminnie.com/clinical-news/womens-imaging/breast/article/15613870/densitas-receives-ce-mark-canadian-clearance","https://www.auntminnie.com/clinical-news/womens-imaging/breast/article/15619076/densitas-deploys-breast-density-software-throughout-canada","https://www.itnonline.com/content/densitas-breast-density-software-receives-iso-certification","https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0597","summary":"DM-Density is an AI-driven software that automates breast density assessment in mammograms, aiding radiologists in evaluating breast tissue composition and associated cancer risk.","description":"DM-Density is an AI-based software developed by Densitas that processes digital mammogram images to automatically calculate breast density, providing numerical values and density grades to assist physicians in assessing breast tissue composition. It integrates seamlessly with mammography workstations or PACS, delivering standardized breast density information following BI-RADS classifications. The software has received regulatory clearances in Canada, the European Union, and the United States, and is available through platforms like EnvoyAI. It has been clinically validated to demonstrate a strong association with breast cancer risk, making it a practical solution for breast screening. Additionally, it has been ISO certified, ensuring compliance with international standards. ([densitashealth.com](https://densitashealth.com/news/densitas-gets-approval-for-canada-eu/?utm_source=openai))","categories":["clinical Care","diagnostic Support","radiology","imaging Software","ai Clinical Documentation Integrity","clinical Decision Support","imaging Software","ai Clinical Documentation Integrity","clinical Decision Support","healthcare It","medical Device","software Development","health Data Analytics","Clinical","Diagnostic","Radiology","Imaging","Ai","Machine Learning","Healthcare It","Medical Device","Software","Healthcare Analytics"],"market_segment":["enterprise","smb"],"target_users":["radiologists","clinicians","medical imaging professionals","healthcare providers","oncologists","breast health specialists"],"specialties":["Radiology","Oncology","Breast Health","Medical Imaging","Healthcare It","Machine Learning","Artificial Intelligence","Medical Devices","Healthcare Analytics","Women's Health","Preventive Medicine","Diagnostic Imaging","Mammography","Medical Software","Healthcare Technology","Medical Diagnostics","Clinical Decision Support","Patient Care","Healthcare Innovation","Medical Research"],"regions_available":["Canada","European Union","United States","Australia"],"languages_supported":["English","French","German","Spanish","Italian","Dutch","Portuguese","Swedish","Danish","Finnish","Norwegian","Greek","Czech","Polish","Hungarian","Romanian","Bulgarian","Slovak","Slovenian","Croatian"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["Canada","United States","European Union","Australia"],"company_founding":"2014","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web","iOS","Android","Windows","macOS","Linux"],"features":["Automated breast density assessment","Image quality evaluation","Breast cancer risk scoring","ACR BI-RADS breast density classification","MQSA/ACR-compliant image quality evaluations","Positioning and technologist feedback","Image-derived breast cancer risk scores","Analytics and reporting tools","Compliance with MQSA EQUIP and ACR accreditation","Workflow and prioritization tools","Point-of-care deployment","Retrospective deployment across clinics and health systems"],"optional_modules":["densityAI","qualityAI","riskAI"],"integrations":["DICOM mammograms","EMR/EHR systems","HIE systems"],"data_standards":["DICOM","HL7","FHIR"],"api_available":"unknown","system_requirements":["Web browser","iOS device","Android device","Windows PC","macOS device","Linux device"],"compliance":["HIPAA","GDPR","HITECH","SOC 2","ISO 27001"],"certifications":["FDA 510(k)","CE/MDR","ONC","ISO 13485"],"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":"SW0597","slug":"dm-density","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/dm-density.json"}}