Saige-Density (2.5.0)
Overview
Saige-Density (2.5.0) by DeepHealth is a Software as a Medical Device (SaMD) designed to automate the assessment of breast tissue composition. Developed for interpreting radiologists and breast imaging specialists, the tool assists in evaluating mammography exams within clinical and screening environments.
The software integrates directly into existing radiology workflows by processing DICOM files from compatible full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) systems. It operates in the background, analyzing 2D mammogram images (including synthetic 2D views) using deep learning algorithms. Rather than utilizing a standalone graphical user interface, Saige-Density outputs its findings directly to the PACS or mammography viewing workstation.
Notable capabilities include:
- Automatic generation of a study-level breast density category aligned with the ACR BI-RADS Atlas 5th Edition (categories A through D).
- Standardized output delivery via two DICOM objects: a Structured Report (SR) containing the case-level density category and a Secondary Capture (SC) summary report.
- Compatibility with leading enterprise imaging viewers, enabling density scores to display directly within CAD headers or image overlays.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Automated breast density categorization (ACR BI-RADS classification)
- Aids interpreting physicians in breast tissue assessment
- Reduces subjectivity and variability in density assessments
- Adjunctive AI software (not a diagnostic aid)
- Compatible with FFDM and DBT systems
- Trained on a diverse database of mammography images
- Part of DeepHealth's Breast Suite for enhanced workflow
- Integrates into existing breast cancer diagnostic workflows
- Provides consistent, automated density classification
- Outputs DICOM Structured Report (SR) and Secondary Capture (SC) objects
Use Cases
- Assessing breast density during mammography exams
- Supporting radiologists in accurate and consistent breast density determinations
- Facilitating earlier identification of breast cancer through improved density assessment
- Aiding compliance with national standards for breast density notification
What Physicians Need to Know
Saige-Density serves as a valuable adjunctive tool to enhance the objectivity and consistency of breast density assessment, which is crucial for patient risk stratification and adherence to regulatory guidelines. Remember that it is an aid and should always be used in conjunction with your comprehensive clinical judgment and review of the mammogram. Leverage its automated categorization to streamline reporting and ensure consistent communication with patients regarding their breast density.
Saige-Density's output in standard DICOM formats (SR and SC) is designed for straightforward integration into existing mammography viewing workstations and PACS/RIS environments. Its compatibility with both FFDM and DBT systems ensures broad applicability. For users within the RadNet ecosystem or those utilizing GE HealthCare's Breast Suite, deeper, more seamless integration and workflow enhancements are likely available.
Details
| Category | Oncology AI, Radiology & Imaging AI |
| Pricing | Contact for pricing |
| Deployment | Cloud-native (DeepHealth OS) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated Saige-Density (2.5.0) received 510(k) clearance (K243705) from the FDA on December 19, 2024. It is an adjunctive AI software intended to aid interpreting physicians in the assessment of breast tissue composition by providing an ACR BI-RADS Atlas 5th Edition breast density category. |
| Integrations | |
| EHR | Not specified |
| Specialties | Oncology, Radiology |
What the Web Says
Saige-Density (2.5.0) is an FDA-cleared artificial intelligence software developed by DeepHealth, Inc. for automated radiological image processing and analysis in mammography and digital breast tomosynthesis (DBT). It functions by outputting DICOM files (structured and secondary capture reports) that are then viewed on a mammography viewing workstation or integrated with existing PACS systems, rather than having its own primary user interface for direct interaction or image review. The software is designed to assist physicians in detecting subtle lesions and improving the accuracy of mammogram interpretations, with studies indicating improved performance for both general radiologists and breast imaging specialists.
Overall: PositiveStrengths
- FDA-cleared for mammography and DBT.
- Improves breast cancer detection rates.
- Enhances accuracy for both general radiologists and breast imaging specialists.
- Identifies subtle lesions that are difficult to find manually.
- Reduces false alarms and patient anxiety.
- Delivers equitable results across diverse patient populations, including women with dense breasts and various racial/ethnic groups.
Limitations
- Lacks its own direct user interface for image review, relying on integration with existing PACS or viewing workstations.
- May lead to a slight increase in recall rates, though balanced by increased cancer detection.
- Information on pricing is not readily available in the search results.
- Specific physician reviews outside of study contexts are not widely published in the provided search results.
- No reviews found on G2, Capterra, or Reddit.
Based on reviews from: Innolitics, Radiology AI Tools Directory, DeepHealth - Physician Ai Tools, FDA, BEUDAMED, Enhanced Breast Cancer Detection, Impact of a Categorical AI System for Digital Breast Tomosynthesis on Breast Cancer Interpretation by Both General Radiologists and Breast Imaging Specialists - PMC, Diagnostic Imaging, Landmark Nature Health Study Demonstrates the Effectiveness of DeepHealth's Novel AI-Powered Breast Cancer Detection Workflow
Last updated: 2026-07-17
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