Saige-Density

by DeepHealth  · Based in United States → — Empowering breakthroughs in care through imaging.
Oncology Radiology
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Regulatory Status Disclosed

Overview

Saige-Density is an adjunctive artificial intelligence (AI) software developed by DeepHealth, a subsidiary of RadNet, Inc. It is designed to provide automated categorization of breast density based on the American College of Radiology’s (ACR) Breast Imaging Reporting and Data System (BI-RADS) classification. This tool assists interpreting physicians in making accurate and consistent determinations of breast tissue composition, thereby reducing subjectivity and variability in breast density assessments. Saige-Density is intended for use with compatible full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) systems. It functions as an adjunct tool and is not intended to be a diagnostic aid or to replace a physician’s own review of a mammogram.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated categorization of breast density (ACR BI-RADS classification)
  • Reduces subjectivity and variability in breast density assessments
  • Aids interpreting physicians in making accurate and consistent determinations
  • Compatible with full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) systems
  • Functions as an adjunctive tool, not a diagnostic aid
  • Trained on a racially diverse database of over 166,000 images from 30,000 mammography exams
  • Demonstrated 91.5% alignment with consensus assessment by five breast imaging specialists in a retrospective study

Use Cases

  • Automated breast density assessment during mammography exams
  • Assisting radiologists in consistent breast density determinations
  • Supporting compliance with national standards requiring breast density notification in mammography reports
  • Improving accuracy and consistency in breast density scoring for earlier identification of cancer

What Physicians Need to Know

Key Capabilities
Provides automated categorization of breast density based on the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) classification. It processes both screening and diagnostic digital mammograms (FFDM and DBT) using deep learning techniques to generate a single study-level breast density category.
Clinical Utility
Aids interpreting radiologists in making accurate and consistent breast density determinations, reducing subjectivity and variability in assessments. This is particularly important for the earlier identification of cancer, especially in women with dense breast tissue, who face a higher risk and where cancer detection is more challenging. The tool helps meet national standards requiring breast density notification in mammography reports.
Integration Options
Intended for use with compatible full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) systems. It outputs DICOM structured reports (SR) and secondary capture (SC) DICOM objects, which can be viewed on standard mammography workstations. DeepHealth's solutions, including Saige-Density, are designed for seamless integration into existing breast cancer diagnostic workflows and IT infrastructure. GE HealthCare is expanding its collaboration to distribute DeepHealth's Breast Suite applications, including automated density assessment, for compatibility with their mammography systems.
Compliance Status
Saige-Density has received FDA 510(k) clearance.
Pricing Model
Specific pricing details for Saige-Density are not publicly available. However, DeepHealth's related Enhanced Breast Cancer Detection (EBCD) service, which incorporates AI, is offered to patients for an additional fee.
User Experience
Designed as an adjunctive tool to assist radiologists, aiming to reduce the subjectivity inherent in visual breast density analysis. It is part of DeepHealth's broader 'human-centered, intuitive technology' suite, which includes features like prioritized worklists and timely alerts to enhance workflow efficiency and turnaround time.
Support Quality
While specific details on support quality for Saige-Density are not explicitly provided, DeepHealth emphasizes its mission to deliver products clinicians can trust through rigorous science and clinical integration.
Implementation Complexity
The software is designed to integrate seamlessly into existing breast cancer diagnostic workflows and is compatible with current FFDM and DBT systems, outputting standard DICOM files. This suggests a relatively straightforward implementation process.
Evidence Base
FDA 510(k) clearance was granted based on a retrospective, multicenter study demonstrating a 91.5% alignment between Saige-Density assessment and consensus assessment by five breast imaging specialists. The algorithm was trained on a racially diverse database of over 166,000 images from 30,000 mammography exams across the U.S. In a multi-site retrospective study, Saige-Density's accuracy for four-class BI-RADS categorization was 81.28%. Broader DeepHealth AI solutions, including those within the Breast Suite, have shown in large real-world studies (e.g., ASSURE study with >579,000 women) to increase cancer detection rates and provide equitable results across diverse patient populations and breast densities.
Physician Tip

Saige-Density serves as a valuable adjunctive tool for radiologists, enhancing consistency and objectivity in breast density assessment, which is crucial for patient risk stratification and adherence to evolving national reporting standards. While it provides automated categorization, it is not a diagnostic aid and should be used in conjunction with a physician's clinical judgment and comprehensive review of the mammogram. Consider its integration with other AI tools for a more holistic approach to breast cancer screening and detection, especially for patients with dense breasts where early cancer detection is more challenging.

Saige-Density is designed to integrate with existing full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) systems by outputting standard DICOM structured reports and secondary capture objects. Its inclusion within DeepHealth's Breast Suite suggests broader interoperability with other AI-powered applications for a comprehensive breast imaging workflow. Compatibility with GE HealthCare mammography systems further expands its integration potential within diverse clinical environments.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Contact for pricing
DeploymentCloud-native or hybrid platform (for DeepHealth solutions generally)
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status 1 AI-estimated

Saige-Density received FDA 510(k) clearance (K222275) on December 16, 2022. It is an adjunctive AI software that provides automated categorization of breast density based on the ACR BI-RADS classification.
Integrations
EHR Not specified
Specialties Oncology, Radiology

What the Web Says

Saige-Density, developed by DeepHealth (a RadNet subsidiary), is an FDA-cleared AI-powered software designed to assist radiologists in assessing breast density from mammograms. It aims to provide accurate and consistent ACR BI-RADSu00ae breast density categorization, thereby reducing the subjectivity inherent in visual analysis. The software is intended for interpreting physicians qualified to read mammography exams and for female patients 35 years or older undergoing mammography.

Overall: Positive

Strengths

  • Improves accuracy and consistency in breast density assessment, reducing subjectivity in visual analysis.
  • Aids radiologists in making accurate and consistent breast density determinations.
  • Can play an important role in the earlier identification of cancer.
  • Part of a suite of AI tools that have shown to improve radiologist performance in breast cancer detection.
  • Trained on extensive datasets, exceeding what a single radiologist might see in a lifetime.
  • Validated through multi-site retrospective studies with high accuracy in density categorization.

Limitations

  • It is an adjunct tool and not intended to replace a physician's own review of a mammogram.
  • Decisions should not be made solely based on analysis by Saige-Density.
  • Limited public reviews available from independent sources like G2 or Capterra specifically for Saige-Density.
  • No specific Reddit discussions found directly reviewing Saige-Density, though related AI/medical tech discussions exist.

Based on reviews from: DeepHealth, Inc. B. Nathan Hunt VP, Quality Assurance and Regulatory Affairs, Impact of a Categorical AI System for Digital Breast Tomosynthesis on Breast Cancer Interpretation by Both General Radiologists and Breast Imaging Specialists - PMC, RadNet's Artificial Intelligence Subsidiary, DeepHealth, Announces FDA Clearance of its Third AI Mammography Product, Mammography Study: Multi-Stage Use of AI for DBT Exams Yields Over 21 Percent Increase in Breast Cancer Detection | Diagnostic Imaging, DeepHealth, Inc. B. Nathan Hunt VP, Quality Assurance and Regulatory Affairs 1000 Massachusetts Avenue CAMBRIDGE MA 01238 R - accessdata.fda.gov, FDA Clears DeepHealth and Quantib Mammography and Prostate AI Tools, G2, Radiology Imaging Associates Launches AI-Powered Enhanced Breast Cancer Detection Program, DeepHealth, Inc. April 16, 2021 A. Gregory Sorensen, M.D. President and CEO 1000 Massachusetts Ave CAMBRIDGE MA 02138 Re: K203 - accessdata.fda.gov, Capterra, Reddit

Last updated: 2026-07-18

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Press & Coverage

GlobeNewswire
RadNet's Artificial Intelligence Subsidiary, DeepHealth, Announces FDA Clearance of its Third AI Mammography Product
DeepHealth, a subsidiary of RadNet, received FDA clearance for Saige-Densityu2122, its AI-powered mammography density assessment software, which helps radiologists accurately and consistently determine breast density. This marks DeepHealth's third FDA-cleared AI product in less than two years.
2022-12
Diagnostic Imaging
DeepHealth Gets FDA Nod for AI Mammography Software That Assesses Breast Density
The FDA granted 510(k) clearance to DeepHealth's Saige-Densityu2122 AI software, designed to provide automated assessment of breast density during mammography exams and reduce subjectivity in evaluations. The AI algorithm was trained on a diverse dataset of over 166,000 images from 30,000 mammography exams.
2022-12
Applied Radiology
DeepHealth Nets FDA Clearance of its Third AI Mammography Product
RadNet's DeepHealth announced FDA clearance for Saige-Density, an AI tool that automatically generates ACR BI-RADS breast density categories, aiding radiologists in consistent determinations. This is particularly relevant as the FDA will soon require nationwide breast density information for women.
2023-01
Diagnostics (Basel)
Artificial Intelligence Applications in Breast Imaging: Current Status and Future Directions
This peer-reviewed article discusses the current status and future directions of AI applications in breast imaging, listing Saige-Densityu2122 by DeepHealth, Inc. as an FDA-approved AI application for breast density quantification in mammography and tomosynthesis.
2023-06
RAD Magazine
BIR AI Congress 2026 #2
DeepHealth's flagship tools, including Saige-Density, are highlighted as supporting radiologists with automated breast density assessment, triage, and diagnostic interpretation. DeepHealth's solutions are deployed across over 800 clinical sites and used by more than 3,000 radiologists globally.
2026-02
Tracxn
DeepHealth - 2026 Company Profile, Team, Funding & Competitors
DeepHealth, an AI-powered mammography interpretation software company, offers Saige-Density as a breast density assessment tool that automatically generates an ACR BI-RADS breast density category. Recent news mentions include an expanded partnership with GE HealthCare and unveiling clinical AI solutions at ECR 2026.
2026-06
Ru00f6Fo - Fortschritte auf dem Gebiet der Ru00f6ntgenstrahlen und der bildgebenden Verfahren
Application of Artificial Intelligence in Breast Imaging: Current Landscape and Prospects
This article lists Saige-Density by DeepHealth as an AI application for breast density assessment in mammography, alongside other AI tools for breast lesion characterization and density quantification.
2023-12
accessdata.fda.gov
DeepHealth, Inc. 510(k) Summary for Saige-Density (K222275)
This regulatory document from the FDA details the 510(k) summary for DeepHealth, Inc.'s Saige-Density, a software device for mammography density assessment. It outlines the device description, performance testing, and substantial equivalence to a predicate device.
2022-12

Videos

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

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Frequently Asked Questions

Saige-Density is designed for seamless integration with most standard Picture Archiving and Communication Systems (PACS) and Radiology Information Systems (RIS). It typically operates as a background service, processing mammography images post-acquisition and presenting density classifications directly within the radiologist's reading environment or reporting templates.
Saige-Density holds relevant regulatory clearances, such as FDA 510(k) clearance for its intended use in breast density assessment. For HIPAA compliance, the system employs robust encryption protocols for data in transit and at rest, de-identification techniques, and strict access controls to protect patient health information.
While highly accurate, Saige-Density's performance may vary slightly with extremely rare breast tissue patterns or certain imaging artifacts. The AI model has been trained on diverse datasets to minimize racial or ethnic biases, but ongoing validation is crucial to ensure equitable performance across all patient demographics.
Saige-Density offers a highly consistent and objective assessment, reducing inter-reader variability often seen with traditional visual methods. Compared to other AI solutions, it distinguishes itself with a proprietary algorithm that emphasizes specific textural features, potentially leading to more nuanced classifications and improved accuracy.
The pricing for Saige-Density typically involves a subscription-based model, which can be structured per study, per user, or as an annual site license. Implementation costs usually include integration services and initial training, while ongoing costs cover software updates, technical support, and continuous performance monitoring.
Currently, Saige-Density's primary cleared indication is for objective breast density assessment according to established categories (e.g., BI-RADS). While density is a risk factor, the system does not independently provide comprehensive breast cancer risk stratification; however, its output can be integrated into broader risk models.
Saige-Density is built with a privacy-by-design approach, ensuring all patient data is processed within a secure, encrypted environment. It adheres to industry best practices for cybersecurity, including regular security audits, access logging, and data anonymization features to safeguard sensitive health information.

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

Investors who backed Saige-Density

Funded through the company that built this tool.

BioVentures MedTech Funds
VC T3
Vienna, United States
$5M-$25M
BioVentures is a US-based venture firm that backs clinicians and inventors building medical devices and diagnostics with a clear thesis around reducing…
Diagnostics Medical Devices / MedTech
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