Imago Systems’ Visual Intelligence Positioned to Address Latest FDA Warnings about Dense Breast Cancer Detection

The U.S. Preventive Services Task Force (USPSTF) has released new draft recommendations for breast cancer screening that endorse biennial screening with mammography beginning at age 40 for all women.

The FDA now requires all women with dense breasts to be notified that their exams may not always find breast cancer, if present, due to the whiteness of their tissues in mammograms. The FDA did not provide any advice to women receiving such notification. Women are very concerned about receiving a problem definition with no new solutions on the horizon.


Imago ICE Reveal™ – Optimized for Dense Breast Cancer Diagnostics

Imago ICE Reveal from Imago Systems, Inc., is designed to assist clinicians during their interpretation and assessment of digital mammograms. (“ICE” stands for “Image Characterization Engine.”)

Imago ICE Reveal is a software-based image post-processing technology for the visualization and characterization of standard FFDM mammograms, as well as synthesized 2D mammograms. The resulting images are intended to reveal far more data from each X-ray view in a current case than is presently available from the original mammograms alone, providing adjunctive support to clinicians in making their case assessments.

This new visual information is revealed through the patented application of three distinct Imago software algorithms to each CC and MLO view in a current screening or callback case, leading to optimized visibility of margins and shapes of the interpretive patterns, both normal and abnormal, that are already well known to radiologists. In addition, for the first time, patterns are revealed inside masses and at their margins to allow clinicians to view details in tumor microenvironments within a standard mammogram.

Each of the three algorithms visualizes and characterizes tissue in a different way…to provide clinically relevant details of normal and abnormal tissues, even in very dense mammograms that are classified as ACR BI-RADS® “c” or “d”. The collective result is a multi-dimensional model of the human breast where all tissues are now much more easily seen, and always within the context of “the rest of the breast,” that is, the normal tissue. Because it is now possible to see the interior structures and textures of cancerous and benign lesions regardless of breast density, clinicians have the potential to make assessment decisions that are based upon more than the presence of calcifications or margin shape alone.