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FDA Grants Clearance of PowerLook Density Assessment for Digital Breast Tomosynthesis

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iCAD has announced U.S. Food and Drug Administration (FDA) clearance of its artificial intelligence software program, PowerLook Density Assessment Version 3.4, which provides an automated method of determining breast density. The software is compatible with iCAD’s digital breast tomosynthesis platform on both GE and Hologic systems.

“Breast density plays a critical role in both risk assessment and accuracy, as mammography sensitivity is reduced to approximately 48% from an average of 98% in those women with dense breasts. Our cutting-edge technology rapidly produces consistent breast density results while reducing the risk of reader variability, enabling radiologists to more easily identify women who might benefit from additional screening,” said Ken Ferry, CEO of iCAD.

According to a recent study published by Kerlikowske et al in Annals of Internal Medicine, between 40% and 50% of women in the United States are considered to have dense breasts, which can increase tumor aggressiveness, as well as mask the presence of tumors in a mammogram.

iCAD’s PowerLook Density Assessment 3.4 delivers automated, rapid, and reproducible assessments of breast density to help identify patients that may experience reduced sensitivity to digital mammography due to dense breast tissue. This technique, based on machine learning, calibrates the patient’s breast density to the appropriate category corresponding to the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) reporting system. 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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