Mammography medical software Breast-SlimView®

medicalultrasound positioning reportingbreast

Breast-SlimView® is a patented clinical decision support software suite for 2D and 3D mammography that uses artificial intelligence to support radiologists and radiographers by prioritizing and highlighting potentially suspicious areas.

Key features and capabilities:

• An information analysis tool for 2D and 3D mammography imaging
• An innovative review tool for diagnosis that displays only relevant information to reduce visual clutter
• Breast density evaluation based on BI-RADS 5th edition
• A 3-level Risk Score analysis
• Integration of prior examinations with comparison capabilities
• A structured positioning report including:
  • Breast density evaluation
  • Negativated images
  • Risk Score for each breast
  • Pictogram projection in Ultrasound indicating areas to consider for complementary examinations

Patent / algorithm:
The product implements a patented technical process called “negativation”: the algorithm detects and removes physiological breast elements (blood vessels, connective tissue, mammary gland, muscles, fat) and replaces them with artificial fat to better reveal potentially suspicious structures. This approach is integrated into the suite to speed up reading of unproblematic cases and allow radiologists to focus on complex cases.

Mammography Technical Evaluation (MTE):
MTE is an image quality assessment and monitoring tool (compatible with 2D and 3D/tomosynthesis) that automatically analyzes criteria such as breast compression, positioning (pectoral muscle, nipple, inframammary fold), technical artifacts and presence of skin folds to help produce optimal images from the first reading. MTE enables radiographers to self-assess and standardize acquisition best practices while giving radiologists objective, reproducible acquisition quality analysis.

Regulatory & deployment notes:
Breast-SlimView® is a CE-certified Class IIa medical device (notified body KIWA 0476) marketed in Europe; an FDA approval process for the United States is in progress.

Technical specifications:

• Product name (commercial): Breast-SlimView®
• Device class: Class IIa (CE certified by KIWA 0476)
• Regulatory status: CE certified; FDA approval in progress
• Clinical scope: Decision support for breast cancer screening and mammography image quality assessment
• Image modalities supported: 2D mammography and 3D tomosynthesis
• Standards: DICOM (integration with standard PACS/workflow)
• Main algorithmic feature: Patented “negativation” process (physiological element removal + artificial fat replacement)
• Outputs: Negativated images, breast density evaluation (BI-RADS 5th), per-breast Risk Score, structured positioning report, pictogram projection for ultrasound guidance
• Installation: On-premises integration into customer infrastructure; no additional hardware required
• MTE: Automated acquisition quality checks (compression, positioning, artifacts)