Saige-Density™

Mammography Density Assessment Software

Automatically make accurate and consistent breast density assessments with the help of Artificial Intelligence.

Saige Density Report

Saige-Density™ uses machine learning to automatically generate an ACR BI-RADS® 5th Edition breast density category to aid radiologists in making accurate and consistent breast density assessments.

How it Works

Saige-Density uses a state-of-the-art AI algorithm to analyze fibroglandular breast tissue and automatically assigns a breast density category (A, B, C, or D) that follows the ACR BI-RADS 5th Edition guidelines for a given mammogram. Radiologists are able to view the outputted density category on their mammography viewing workstation.

Saige-Density integrates seamlessly into the clinical workflow, making it easy for radiologists to access the results. Along with the breast density classification, Saige-Density produces an indicator bar that displays the ranking of the exam within the specific density category. The indicator bar helps radiologists visualize where the exam falls within the outputted density category.

Saige Density Category

Indicator bar displays relative ranking of the exam within density category.

Performance

Saige-Density delivers highly accurate and reproducible breast density classifications. In a retrospective, multi-center study, Saige-Density exhibited 91.5% alignment with the consensus of five breast imaging specialists on dense (C, D) vs non-dense (A, B) categorization. Saige-Density’s performance is consistently accurate across a wide range of race/ethnicity, age, breast density, modality (FFDM and DBT), exam type (screening and diagnostic), and manufacturers (Hologic and GE). Saige-Density’s AI algorithm was trained using a racially diverse dataset of over 166,000 images (30,000 exams) from regions across the United States.

Saige Density Case Level Density Grade

The density category can be displayed as an overlay on the original mammography images.

Saige-Density Benefits

Eliminates the subjectivity in breast density measurements inherent in visual analysis.

Helps radiologists make more accurate breast density assessments, which can better inform referring physicians and patients of the need for supplemental imaging.

Has the potential to reduce radiologist variability, helping achieve more reliable measurements.

Helps radiologists have confidence in delivering reliable and consistent assessments to patients.

Implementing Saige-Density

  • No PHI is moved outside of the clinic or hospital
  • Helps mammography facilities meet compliance requirements
  • Outputs compliant with DICOM standards
  • Can be configured to receive and send data from any PACS system seamlessly

This product is currently under evaluation by the Food and Drug Administration. These statements have not been evaluated by the Food and Drug Administration. This device is not intended to diagnose, treat, cure or prevent disease.

Ready to learn more?

Contact us to hear more about Saige-Density.