Artificial Intelligence Software Solution Granted Clearance by FDA
Posted: Monday, August 20, 2018
The U.S. Food and Drug Administration (FDA) recently granted clearance to iCAD for its artificial intelligence software solution, PowerLook Density Assessment Version 3.4. The software is compatible with iCAD’s digital breast tomosynthesis platform on both GE and Hologic systems. This technology is intended to produce consistent breast density results while reducing the risk of reader variability.
According to a recent study published by Karla Kerlikowske, MD, of San Francisco Veterans Affairs Medical Center, and colleagues in the 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 on a mammogram.
The software solution reportedly delivers automated, rapid, and reproducible assessments of breast density to help identify patients who may experience reduced sensitivity to digital mammography as a result of 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.
