DM-Density

by Densitas  · Based in Canada → — Unify Mammography Quality & High-Risk Patient Management.
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
DM-Density (now densitas densityai™) automatically assesses breast density on digital mammograms, providing ACR BI-RADS density scale assessments (4th and 5th Edition) and quantitative percent mammographic density (0%-100%). It aims to eliminate subjectivity and improve reproducibility in breast density assessment. The software can process approximately 600 cases per hour. It is part of the broader intelliMammo® platform, which also includes modules for image quality evaluation (densitas qualityai™) and breast cancer risk assessment (densitas riskai™).
Clinical Utility
DM-Density aids interpreting physicians in assessing breast tissue composition, supporting the development of consistent follow-up screening protocols. It helps in standardizing breast density classification at the point-of-care and supports compliance with federal and regional breast density notification laws. By providing objective and reliable density scores, it assists in stratifying patient risk for tailored follow-up screening and can help direct attention to patients at highest risk. It is intended to provide adjunctive information and is not a diagnostic aid.
Integration Options
DM-Density is designed for seamless integration into existing reporting and PACS workflows. It can generate results as a DICOM mammography Structured Report or Secondary Capture for viewing on a mammography workstation or PACS. Output may also be transmitted to a RIS. Densitas has partnered with companies like Kailo Medical to integrate breast density measures directly into radiologist reports via KailoHub, and with Blackford to integrate additional software applications into the Blackford Platform. It was also offered through EnvoyAI's distribution platform.
Compliance Status
DM-Density (densitas densityai™) has received CE Mark from the European Commission, a medical device license from Health Canada, and FDA 510(k) clearance in the U.S. It supports compliance with national standards and guidelines, including FDA MQSA EQUIP and breast density inform legislation. The company also holds ISO certification for its quality management systems.
Pricing Model
Unknown
User Experience
The software processes images automatically and generates on-demand results for radiological technologists and radiologists at the point of care. It also provides retrospective analysis at a clinic and health system level through an advanced analytics platform. The aim is to streamline workflows and reduce radiologist dictation time by automating breast density scoring.
Support Quality
Unknown
Implementation Complexity
DM-Density is a standalone software application that integrates seamlessly with PACS systems. It is designed for streamlined deployment within hospital networks and clinics, with alternative configuration options available to match user preferences.
Evidence Base
Studies have shown excellent agreement between radiologists' visual assessments and DM-Density's automated algorithm using BI-RADS 5th edition classifications. Research indicates that the software produces density measures that predict breast cancer risk, suggesting its utility in stratifying women's risk by analyzing digital mammograms. One study found that women with extremely dense breasts had five times higher odds of screen-detected breast cancer compared to those with almost entirely fatty breasts, with BI-RADS density classification automatically assigned by DM-Research (a related Densitas technology).
Physician Tip

DM-Density (densitas densityai™) provides an objective and standardized assessment of breast density, which is crucial for consistent patient management and compliance with breast density notification laws. Remember that it provides adjunctive information and is not a diagnostic aid; clinical judgment remains paramount. Integrating this tool can help streamline workflows and reduce the subjectivity often associated with visual breast density assessment. Utilize the BI-RADS density categories provided to guide discussions with patients about personalized screening plans and potential supplemental imaging, especially for those with extremely dense breasts, as dense tissue can mask cancers and is associated with increased cancer risk.

DM-Density is designed for seamless integration with existing PACS and reporting systems, delivering results in DICOM Structured Reports or Secondary Capture. Partnerships with companies like Kailo Medical and Blackford further enhance its integration capabilities within broader imaging platforms and radiologist workflows, aiming to standardize measurements and reduce dictation time. The availability through platforms like EnvoyAI also suggests flexible deployment options, including on-premise or cloud-based solutions.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Unknown
DeploymentCloud-based, integrates with PACS and RIS.
API AvailableUnknown
Data ExportUnknown
TrainingUnknown
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Oncology, Radiology

Support & Reliability

Training ProvidedUnknown

What the Web Says

DM-Density, developed by Densitas, Inc., is a software application designed to automatically analyze full-field digital mammograms to calculate breast tissue composition and generate a Breast Density Grade according to BI-RADS density classification scales. It is intended to provide adjunctive information to aid interpreting physicians in assessing breast tissue composition and is not a diagnostic aid. The software has been validated on Hologic's Selenia Dimensions and Lorad Selenia systems and can process approximately 600 cases per hour. DM-Density was granted 510(k) premarket notification by the FDA in 2018.

Overall: Positive

Strengths

  • Automated breast density assessment provides objective and reliable measures compared to radiologist-assigned scores.
  • Can process a high volume of cases (approximately 600 per hour).
  • Provides numerical values for fibroglandular tissue, breast area, and area-based breast density.
  • Generates Breast Density Grade in accordance with BI-RADS density classification scales (4th and 5th editions).
  • Offers alternative configuration options to match user preferences.
  • Excellent agreement between radiologists and DM-Research breast density assessment software using BI-RADS 5th edition classifications.

Limitations

  • Independent research using DM-Density has been limited.
  • Not intended as a diagnostic aid.
  • Currently only cleared in Canadian and European markets (as of May 2017). (Note: FDA clearance was granted in Feb 2018)

Based on reviews from: nih.gov, thno.org, mdpi.com, bmj.com, researchgate.net, fda.gov, auntminnie.com, auntminnieeurope.com, densitashealth.com, ajronline.org, spandidos-publications.com, scribd.com, car-asm.ca

Last updated: 2026-10-29

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Press & Coverage

NIH.gov
DM-Density (Densitas) Mammography, Density assessment, 2/23/2018
DM-Density, developed by Densitas, received FDA approval on February 23, 2018, for mammography density assessment.
2018-02
AuntMinnie.com
Densitas receives CE Mark, Canadian clearance
Densitas' DM-Density breast density assessment software received CE Mark from the European Commission and a medical device license from Health Canada in November 2015, allowing sales and installation in Canada and Europe.
2015-11
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 mammograms.
2016-01
densitashealth.co.uk
Densitas' Machine Learning Software for Breast Health Available On EnvoyAI Platform
In November 2017, Densitas announced that its DM-Density software, a machine learning application for automated breast density assessments, would be available through EnvoyAI's distribution platform.
2017-11
Le Lézard
Government of Canada invests in women's health solution through Build in Canada Innovation Program
In November 2017, the Government of Canada invested $565,069 in Densitas Inc. for its DM-Density software, aiming to improve mammography quality and personalized follow-up care for women.
2017-11
AuntMinnie.com
Densitas deploys breast density software throughout Canada
Densitas began rolling out its DM-Density software across Canada in November 2017, including a province-wide installation in Nova Scotia as part of a government innovation program.
2017-11
AuntMinnie.com
Densitas secures $250K investment
In October 2015, Densitas received a $250,000 investment from Innovacorp, a Nova Scotia-based venture capital firm, to further develop its DM-Density tool for breast density assessment.
2015-10
FDA.gov
densitas densityai™ (formerly DM-Density™) 2.5.0
In February 2020, Densitas densityai™ (formerly DM-Density™) 2.5.0 received FDA clearance, indicating substantial equivalence to the predicate device, DM-Density 2.1.0b.
2020-02

Videos

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

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Frequently Asked Questions

DM-Density is a software application that analyzes full-field digital mammograms to calculate breast tissue composition and provide a breast density grade. This information is crucial because women with dense breasts have a four-to-six times greater risk of developing breast cancer, and tumors are harder to detect visually in dense tissue. By providing accurate and automated breast density assessments, DM-Density helps radiologists in evaluating breast cancer risk and triaging women for appropriate diagnostic procedures and follow-up screening protocols.
DM-Density received the CE Mark from the European Commission and a medical device license from Health Canada around early 2016. The process for FDA clearance for DM-Density was underway as of 2016. The software is intended for use with compatible full-field digital mammography systems and provides adjunctive information, but it is not a diagnostic aid itself.
While AI tools offer significant potential, concerns exist regarding their integration into clinical practice. These include the risk of AI systems generating incorrect information (hallucination rate), potential biases in datasets leading to lower diagnostic accuracy in underrepresented populations, and the challenge of integrating AI into busy and complex clinical workflows that may lack sufficient technical infrastructure. Additionally, some AI models act as 'black boxes,' making it difficult for physicians to explain their reasoning to patients, and there's a risk of clinicians becoming over-reliant on AI recommendations, potentially leading to deskilling.
Yes, there are other methods for breast density assessment. These include area-based approaches like BI-RADS and semi-automated Cumulus, as well as fully-automated volumetric methods such as Volpara, Quantra, and single energy x-ray absorptiometry (SXA). Studies have shown varying associations with breast cancer risk among these methods, with Volpara and Cumulus often showing higher risk increments per standard deviation in percent density compared to ImageJ-based methods, Quantra, and SXA.
The provided information does not contain specific pricing details for DM-Density. Generally, pricing for medical AI software can vary significantly based on factors such as the specific features, integration requirements, and the vendor's business model.

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densitas densityai
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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

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