DenSeeMammo

by Statlife  · Based in United States → — Automated Breast Density Assessment for Radiologists
Radiology
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Regulatory Status Disclosed

Overview

DenSeeMammo, developed by Statlife, is an AI-powered software solution designed for automated breast density category assessment from digital mammography images. It provides a standardized evaluation that mimics radiologists’ visual assessment, adhering to the BI-RADS 5th Edition guidelines. The software analyzes processed 2D mammograms by comparing them to a qualified database of images previously assessed by Mammography Quality Standards Act (MQSA) certified radiologists. This fully automated procedure generates a BI-RADS breast density category (A, B, C, or D) to aid radiologists in their assessment.

DenSeeMammo is intended to provide adjunctive information and is not an interpretive or diagnostic aid; the final assessment of breast density remains the responsibility of a qualified interpreting physician. It is compatible with images obtained from GE Senographe Essentials and Hologic Selenia Dimension mammography systems. When combined with Statlife’s MammoRisk software, DenSeeMammo can contribute to a comprehensive breast cancer risk assessment and the development of personalized screening programs.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated breast density evaluation
  • Standardized assessment according to BI-RADS 5th Edition guidelines
  • Mimics radiologists' visual assessment
  • Compares images to a database of MQSA-qualified radiologist-assessed images
  • Provides BI-RADS breast density 5th Edition category (A, B, C, D)
  • Provides adjunctive information to aid radiologists
  • Compatible with GE Senographe Essentials and Hologic Selenia Dimension mammography systems
  • Can be combined with MammoRisk for breast cancer risk assessment and personalized screening programs
  • Fully automated comparison procedure
  • Web application with graphical user interface

Use Cases

  • Breast density assessment in mammography screening programs
  • Assisting radiologists in consistent and reproducible breast density evaluation
  • Providing objective breast density information to potentially improve screening and diagnosis
  • Integration into comprehensive breast cancer risk assessment workflows
  • Supporting women's healthcare professionals in personalized screening program recommendations

What Physicians Need to Know

Key Capabilities
DenSeeMammo provides standardized, automatic breast density evaluation on 2D mammograms, mimicking radiologists' visual assessment per BI-RADS 5th Edition guidelines (categories A, B, C, D). It uses AI to compare images against a database of MQSA radiologist-assessed mammograms, offering reproducible results. The software can be combined with MammoRisk for comprehensive breast cancer risk assessment and personalized screening recommendations.
Clinical Utility
This tool aids radiologists by providing consistent and reproducible breast density assessments, addressing the subjectivity inherent in manual visual evaluations. It helps identify women with dense breasts, who are at a higher risk of breast cancer and for whom mammography sensitivity is reduced due to the masking effect. DenSeeMammo's assessment of breast density is positively associated with the risk of incident and interval cancers.
Integration Options
DenSeeMammo is a software application compatible with digital mammography systems, specifically noted for GE Senographe Essentials and Hologic mammography systems. It operates in a client-server mode, requiring the user computer to be on the same local network as the server, with a web browser for the graphical user interface. It is designed to integrate with Predilife's MammoRisk software for combined risk assessment.
Compliance Status
DenSeeMammo has received U.S. FDA 510(k) clearance (initially in 2016, with updates in 2017 and 2018 for GE and Hologic equipment) and is CE marked. It adheres to BI-RADS 5th Edition guidelines for breast density classification.
Pricing Model
Specific pricing details for DenSeeMammo are not publicly available in the provided information.
User Experience
The software offers a fully automated and reproducible method for breast density assessment, aiming to reduce the variability and time associated with manual visual assessments. Its graphical user interface is accessible via a web browser, and it provides results per patient based on the maximum density category of the two breasts. Studies indicate a strong correlation between DenSeeMammo's AI evaluation and radiologists' visual assessments.
Support Quality
No specific details regarding support quality for DenSeeMammo are available in the provided information.
Implementation Complexity
Implementation involves a client-server architecture, meaning the software runs on a local server within the facility's network. Compatibility with specific digital mammography systems (e.g., GE Senographe Essentials, Hologic) is a key consideration, suggesting a need for compatible hardware and IT setup.
Evidence Base
DenSeeMammo's effectiveness is supported by a pooled analysis of 14,267 2D mammograms, demonstrating its ability to predict incident cancer risk as non-inferior to radiologists' visual assessment. It also showed a stronger correlation with interval cancers, highlighting its utility in identifying the masking effect of breast density. The software was developed in collaboration with prominent academic centers like Gustave Roussy and Institut Curie, and Predilife is a partner in the European MyPeBS study.
Physician Tip

DenSeeMammo serves as a valuable adjunctive tool for breast density assessment, offering a standardized and reproducible evaluation that can significantly reduce inter-observer variability. Physicians should leverage its automated BI-RADS classification to enhance the accuracy of breast density reporting, especially in light of evolving FDA mandates for patient notification. Combining DenSeeMammo with risk assessment tools like MammoRisk can facilitate personalized screening strategies, ensuring that women with dense breasts, who are at higher risk and have reduced mammography sensitivity, receive appropriate follow-up imaging or tailored surveillance programs. Remember that it provides adjunctive information and the final assessment remains with the qualified interpreting physician.

DenSeeMammo is designed for integration with existing digital mammography systems, specifically mentioning compatibility with GE Senographe Essentials and Hologic equipment. Its client-server architecture implies a local network setup. The most direct integration benefit is its seamless combination with Predilife's MammoRisk software, creating a comprehensive platform for both breast density assessment and personalized breast cancer risk prediction.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Unknown
DeploymentClient-server mode, web application
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

DenSeeMammo is an FDA-cleared software solution (K173574, cleared June 26, 2018) for breast density category assessment. It provides a standardized and automatic breast density evaluation according to BI-RADS 5th Edition guidelines, intended to aid radiologists. It is not an interpretive or diagnostic aid for final assessment, which remains with a qualified physician. The software is compatible with images from GE Senographe Essentials and Hologic Selenia Dimension mammography systems.
Integrations
EHR Not specified
Specialties Radiology

What the Web Says

DenSeeMammo is an FDA-cleared software solution by Predilife (formerly Statlife) that automatically assesses breast density from 2D digital mammograms, standardizing the evaluation according to BI-RADS 5th Edition guidelines. It aims to provide a reproducible assessment that mimics a radiologist's visual evaluation and can be combined with Predilife's MammoRisk software for breast cancer risk assessment. Studies have shown that DenSeeMammo's automated breast density assessment is non-inferior to a radiologist's visual assessment in predicting breast cancer risk.

Overall: Positive

Strengths

  • Standardized and automated breast density evaluation.
  • Reproducible results, reducing inter- and intra-observer variability.
  • Mimics radiologists' visual assessment according to BI-RADS 5th Edition.
  • Non-inferior to radiologists' visual assessment in predicting breast cancer risk.
  • Stronger marker for interval cancers, indicating its ability to capture the masking effect of breast density.
  • Compatible with images from GE Senographe Essentials and Hologic equipment.

Limitations

  • Limited information available from independent tech reviewers, G2, or Capterra.
  • Reddit discussions highlight general concerns about dense breast tissue and mammogram limitations, not specific to DenSeeMammo.
  • Initial FDA clearance in 2016, with an update in 2018, suggesting it has been on the market for some time without widespread public reviews.
  • The software provides adjunctive information and is not an interpretive or diagnostic aid for the final assessment of breast density.

Based on reviews from: Imaging Technology News, PMC (PubMed Central), Reddit

Last updated: 2026-07-19

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Press & Coverage

Actusnews Wire
PREDILIFE: BILAN DE L'ANNEE ET RESULTATS ANNUELS 2025
Predilife announced its 2025 annual results, highlighting the DenSeeMammo + MammoRisk system, now named Denseerisk. This combined device is compared to Clairity, the only FDA-approved device for risk prediction using only images.
2026-06
PMC
Validation of a new fully automated software for 2D digital mammographic breast density evaluation in predicting breast cancer risk - PMC
This study validates DenSeeMammo 1.2, an FDA-approved, fully automated software for assessing breast density and predicting breast cancer risk. It provides a BI-RADS category density grade based on comparisons with databases of radiologist-scored images.
2021-10
PMC
Feasibility of personalized screening and prevention recommendations in the general population through breast cancer risk assessment: results from a dedicated risk clinic - PMC
This article discusses the feasibility of personalized breast cancer screening using tools like MammoRisk and DenSeeMammo, which estimates breast density. The study highlights how these tools contribute to individualized risk assessment and tailored screening recommendations.
2022-01
AuntMinnieEurope
AI scores high marks for rating breast density | AuntMinnieEurope
A 2019 study found that Predilife's DenSeeMammo AI software performed almost as well as senior radiologists in evaluating breast density and five-year breast cancer risks. The algorithm showed substantial agreement with both senior and junior radiologists.
2020-08
Actusnews Wire
The Paris Breast Center [L'Institut du Sein Paris] and Predilife announcing that they have established a partnership to introduce breast cancer risk consultations.
The Paris Breast Center and Predilife partnered to offer breast cancer risk consultations, utilizing Predilife's MammoRisk predictive test and DenSeeMammo software for breast density measurement.
2020-11
Mena Medical Development
MMD X MammoRisku00ae: Become a RISK-TAKER! - Mena Medical Development
MMD Group announced a partnership with Predilife to bring personalized predictive medicine solutions, including MammoRisk and the FDA-approved and CE-marked DenSeeMammo, to the MENA region. DenSeeMammo is an AI-based solution that classifies breast density according to BI-RADS V categories.
2021-09
Imaging Technology News
FDA Clears DenSeeMammo Breast Density Category Assessment Software
The U.S. Food and Drug Administration (FDA) granted 510(k) clearance to Statlife's (now Predilife) DenSeeMammo, a software solution for breast density category assessment. The software provides a standardized and automatic breast density evaluation that mimics radiologists' visual assessment.
2016-12
Actusnews Wire
PREDILIFE Société anonyme au capital de 93.006,92 euros Siège social : 39, Rue Camille Desmoulins – 94805 Villejuif 453.164 - ActusNews.com
Predilife's 2023 financial report mentions DenSeeMammo as a breast density measurement software.
2024-04

Videos

Product demos, reviews, and walkthroughs for DenSeeMammo.

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Frequently Asked Questions

DenSeeMammo is an FDA 510(k) cleared software solution designed for automated breast density category assessment using BI-RADS 5th Edition guidelines. It integrates by analyzing digitally processed 2D mammograms to provide a standardized breast density evaluation, serving as adjunctive information to aid radiologists in their assessment. The software is compatible with specific digital mammography systems, such as GE Senographe Essentials and Hologic Selenia Dimension, and can operate in a client-server mode via a web application.
DenSeeMammo has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its breast density assessment capabilities. While specific details on data privacy protocols like HIPAA are not explicitly detailed in the provided information, as an FDA-cleared medical device software, it would be expected to adhere to relevant healthcare data security and privacy regulations. The software is intended to provide adjunctive information, with the final assessment remaining the responsibility of a qualified physician, which is a key aspect of its regulatory clearance.
DenSeeMammo provides a standardized and reproducible breast density evaluation that has been shown to be non-inferior to radiologists' visual assessment in predicting breast cancer risk. Other automated systems like Volpara, Quantra, and Densitas also exist for breast density assessment. While DenSeeMammo focuses on automated BI-RADS categorization, other AI tools may offer additional functionalities like lesion detection or risk assessment, and various imaging techniques such as 3D mammography (DBT), ultrasound, MRI, and contrast-enhanced mammography serve as alternatives or complements for dense breasts.
A primary limitation is that DenSeeMammo is an adjunctive tool and not a diagnostic aid; the final breast density assessment must be made by a qualified interpreting physician. It is also compatible with a limited range of mammography equipment, specifically GE Senographe Essentials and Hologic Selenia Dimension systems. While it aims for reproducibility, the inherent challenges of mammography, such as dense breast tissue masking cancers, still necessitate careful clinical judgment and potentially supplemental screening.
Specific pricing models for DenSeeMammo are not publicly available in the provided search results. Generally, AI software solutions in healthcare can involve various pricing structures, such as per-study fees, subscription models, or one-time licensing. The cost-effectiveness would likely be evaluated based on factors like improved workflow efficiency, enhanced consistency in breast density reporting, and its potential contribution to personalized screening programs when combined with risk assessment tools.
DenSeeMammo aims to provide a reproducible breast density assessment, which can help standardize reporting and potentially reduce inter-reader variability in density classification. For women with dense breasts, where mammography alone can miss cancers (false negatives), an accurate and consistent density assessment by DenSeeMammo can inform the need for supplemental screening. While it aids in identifying women who may benefit from additional imaging due to dense tissue, it is not an interpretive or diagnostic aid for cancer detection itself.
By providing a standardized and automatic BI-RADS breast density category, DenSeeMammo helps physicians accurately identify patients with dense breasts, who are at a higher risk for breast cancer and for whom mammography may be less effective. This information is crucial for tailoring personalized screening programs, as women with dense breasts may benefit from supplemental imaging like ultrasound or MRI. DenSeeMammo can also be combined with Statlife's MammoRisk software to provide a comprehensive risk evaluation and personalized screening recommendations.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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