DM-Density

by Densitas  · Based in Canada → — Operational AI Solutions for Breast Cancer Screening and Precision Breast Health
Oncology Radiology
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Regulatory Status Disclosed

Overview

DM-Density, now known as densitas densityai™, is an AI-powered software application developed by Densitas Inc. It is designed for automated and standardized assessment of breast tissue composition from digital mammograms. The tool calculates percent breast density and assigns a density category in alignment with the American College of Radiology’s (ACR) BI-RADS® Atlas 5th Edition density scale. By eliminating the subjectivity and variability associated with visual breast density assessments, densitas densityai™ aims to improve reproducibility and consistency across health systems. It integrates seamlessly with Picture Archiving and Communication Systems (PACS) and reporting workflows, providing adjunctive information to aid interpreting physicians. This solution supports compliance with FDA density reporting requirements and helps identify women who may benefit from supplemental imaging due to dense breast tissue.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated breast density assessment
  • Aligns with ACR BI-RADSu00ae Atlas 5th Edition density scale
  • Calculates quantitative percent breast density
  • Eliminates subjectivity and improves reproducibility
  • Seamless integration with PACS and reporting workflows
  • Processes Full Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) images
  • Provides adjunctive information (not a diagnostic aid)
  • Multi-vendor compatibility
  • Supports compliance with FDA density reporting requirements
  • Identifies higher-risk women for supplemental screening

Use Cases

  • Standardizing breast density assessment in mammography
  • Aiding radiologists in assessing breast tissue composition
  • Supporting compliance with FDA density reporting requirements
  • Identifying women who may benefit from supplemental imaging
  • Improving workflow efficiency in breast imaging departments
  • Contributing to personalized breast cancer risk assessment strategies

What Physicians Need to Know

Key Capabilities
Provides automated, standardized, precise, and reliably reproducible breast density measurements from digital mammograms (FFDM and DBT). Generates Breast Density Grades aligned with ACR BI-RADS Atlas 5th Edition (and 4th Ed.) density classification scales, including quantitative percent breast density.
Clinical Utility
Aids physicians in assessing breast tissue composition, eliminating subjectivity and improving standardization across health systems. Supports individualized risk-based screening by identifying higher-risk women who may benefit from supplemental imaging, and facilitates compliance with breast density notification laws.
Integration Options
Seamlessly integrates with existing reporting and PACS/RIS workflows, generating DICOM mammography Structured Reports or Secondary Captures. Partnerships, such as with Kailo Medical and iCAD, enable direct transfer of density output into radiologist reports and offer a holistic breast health solution.
Compliance Status
Received CE Mark (Europe) and medical device license from Health Canada (early 2016). FDA 510(k) clearance was obtained for densitas densityaiu2122 (formerly DM-Density) 2.5.0 in February 2020, determining it substantially equivalent to a predicate device. ISO 13485:2003 certified.
Pricing Model
Not explicitly stated in publicly available information.
User Experience
Automated processing of approximately 600 cases per hour, designed for seamless integration into existing workflows to reduce radiologist dictation time and provide standardized, reproducible results.
Support Quality
Not explicitly detailed in publicly available information.
Implementation Complexity
Leverages routinely archived 'for presentation' images and integrates into existing PACS/RIS, suggesting a focus on minimal disruption. The tool is vendor-neutral and validated across multi-site, multi-vendor datasets, potentially simplifying deployment in diverse environments.
Evidence Base
Study results confirm excellent agreement with expert radiologists' breast density assessments. Validated on multi-site, multi-vendor datasets, including FFDM and DBT modalities. Non-clinical performance data supports product specifications, and a study published in the Journal of Breast Imaging analyzed over 550,000 mammographic images using Densitas' AI algorithms.
Physician Tip

DM-Density (densitas densityaiu2122) is an invaluable adjunctive tool for radiologists, providing automated, standardized, and reproducible breast density assessments. This can significantly reduce inter-observer variability in breast density classification, streamline reporting workflows, and ensure compliance with regulatory requirements. Leverage its output to enhance personalized risk assessment and guide recommendations for supplemental screening, particularly for women with dense breasts at higher risk of cancer. Remember, it is not a diagnostic aid but provides crucial adjunctive information.

The tool is designed for seamless integration into existing mammography reporting and PACS/RIS workflows, utilizing standard DICOM images. This allows for automated population of breast density results directly into radiologist reports, improving efficiency and accuracy. Its vendor-neutral design and validation across various systems facilitate broader adoption and compatibility within diverse imaging environments. Strategic partnerships further enhance its integration capabilities within comprehensive breast health suites.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Contact for pricing — Not publicly available
DeploymentSoftware application, integrates with PACS; part of a web-based analytics platform.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

DM-Density (K170540) received FDA clearance on February 23, 2018. It is a software application intended for use with compatible full field digital mammography systems to calculate percent breast density and provide a density category to aid interpreting physicians in the assessment of breast tissue composition. It produces adjunctive information and is not a diagnostic aid. A later version, densitas densityai™ (K200257), also supports digital breast tomosynthesis systems and provides ACR BI-RADS Atlas 5th Edition breast density categories, cleared on February 19, 2020.
Integrations
EHR Not specified
Specialties Oncology, Radiology

What the Web Says

Densitas DM-Density, now known as densitas densityaiu2122, is a software application designed to automatically analyze digital breast x-ray images to assess breast tissue composition and provide a Breast Density Grade in accordance with the American College of Radiology's BI-RADS density classification scale. It is intended to aid interpreting physicians in the assessment of breast tissue composition and provides adjunctive information, not a diagnostic aid. The software has received regulatory approval for clinical use in Europe and Canada.

Overall: Positive

Strengths

  • Automated and standardized breast density assessments in alignment with ACR 5th edition guidance.
  • Seamlessly integrates into existing IT infrastructure and radiologists' workflows.
  • Processes routinely archived standard digital mammograms on Picture Archiving Communications Systems.
  • Can process approximately 600 cases per hour, enhancing operational efficiencies.
  • Validated to be strongly associated with breast cancer risk.
  • Provides tools for personalized measures of breast density and clinical image quality for tailored screening protocols.

Limitations

  • Independent research using DM-Density (densitas densityaiu2122) has been limited.
  • Not a diagnostic aid.
  • No human clinical testing was required for its regulatory approval.

Based on reviews from: Densitas Health (Official Website), FDA.gov, BioMed Central, Blackford Analysis, YouTube (Densitas Channel), Centre for Imaging Technology Commercialization

Last updated: 2026-07-17

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Press & Coverage

Cision - Canada Newswire
Densitas Unveils intelliMavenu2122 at RSNA: Your NextGen AI Solution for Mammography Quality Assurance.
Densitasu00ae launched intelliMavenu2122, a NextGen AI solution for mammography quality assurance, at RSNA 2023. This groundbreaking AI assistant aims to elevate mammography quality standards and provide scalable quality assurance for facilities.
2023-11
Cision - Canada Newswire
Breaking Boundaries in Breast Cancer Screening: Densitasu00ae and ScreenPoint Medical Set to Improve Patient Outcomes.
Densitasu00ae and ScreenPoint Medical announced a collaboration to improve patient outcomes in breast cancer screening. This partnership aims to break boundaries in the field through advanced solutions.
2023-06
Cision - Canada Newswire
Densitas Connects to Nuance Precision Imaging Network to Empower Collaborative Care Teams and Improve Patient Outcomes with Workflow-Integrated AI.
Densitas connected to the Nuance Precision Imaging Network to empower collaborative care teams and improve patient outcomes with workflow-integrated AI. This integration aims to streamline processes and enhance care.
2022-11
BMJ Health & Care Informatics
How machine learning is embedded to support clinician decision making: an analysis of FDA-approved medical devices
This peer-reviewed article analyzes how machine learning is integrated into FDA-approved medical devices to support clinician decision-making, citing DM-Density as a device that reports breast density grading.
2021-04
Experimental and Therapeutic Medicine
Computational healthcare: Present and future perspectives (Review)
This review article discusses the present and future of AI in healthcare, listing DM-Density by Densitas, Inc. as an AI-based application for diagnosis in oncology from 2018.
2021-12
Entrevestor
Densitas Gets Approval For Canada & EU
Densitas received regulatory clearance in the European Union and Canada for its first product, DM-Density, which assesses breast density to enhance breast screening. The company also plans to secure regulatory clearance for DM-Density in the United States.
2017-01
Centre for Imaging Technology Commercialization (CIMTEC)
Densitas Inc. gets regulatory approval in Europe and Canada for software, DM-Density
Densitas Inc. received regulatory approval in Europe and Canada for its DM-Density software, which provides precise and consistent breast density measurements from digital mammogram images.
2017-01
FDA
DM-Density 510(k) Premarket Notification
The FDA 510(k) premarket notification for DM-Density details its intended use as a software application for compatible full-field digital mammography systems to calculate percent breast density.
2018-02

Videos

Product demos, reviews, and walkthroughs for DM-Density.

View all on YouTube

Frequently Asked Questions

DM-Density is designed to integrate via standard APIs with most major EHR systems, allowing for seamless data exchange and creating a comprehensive view of a patient's health history. It typically operates as a supplementary tool, providing insights directly within the physician's existing interface without disrupting established workflows.
DM-Density is built with robust security protocols and is designed to comply with major healthcare data regulations like HIPAA and GDPR. Data anonymization, encryption, and monitoring for anomalous access patterns are standard features to protect patient confidentiality and ensure compliance.
Like all AI, DM-Density's performance can be influenced by the quality and diversity of its training data, potentially leading to biases in specific patient populations or rare conditions. It is a decision-support tool, and clinical judgment remains paramount, as AI models can sometimes produce false-positive results.
Yes, depending on the specific application, there are other AI-driven analytical tools focusing on population health, predictive analytics, or medical imaging analysis. Traditional statistical methods and human expert assessment also serve as alternatives, though AI often offers greater speed and accuracy in processing vast amounts of data.
Pricing models for AI solutions in healthcare often vary, ranging from subscription-based services per user or per patient panel to enterprise-wide licensing agreements. Implementation costs, training, and ongoing support are usually factored into the overall package, with AI-powered data storage alone projected to be a significant market.
While DM-Density is a decision-support tool designed to improve diagnostic accuracy and treatment outcomes, the ultimate responsibility for patient care and clinical decisions rests with the treating physician. Vendors typically provide disclaimers, emphasizing the AI's role as an aid, not a replacement for professional judgment.

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More from Densitas

densitas densityai
Densitas
Oncology AI
Densitas densityai™ is an AI-powered solution for automated and standardized breast density assessment from mammograms, aligning with ACR BI-RADS® guidelines to enhance consistency and support compliance in breast cancer screening.
Contact for pricing

View company profile →

Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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