iCAD gains FDA clearance for AI software that calculates breast density

The software, compatible with iCAD's digital breast tomosynthesis solutions, uses artificial intelligence to assess patients' breast density. "At iCAD, we continually strive to provide radiologists with the most advanced, accurate and efficient software solutions designed for the early detection of breast cancer," Ken Ferry, CEO of iCAD, said in a prepared statement. "Breast density plays a critical role in both risk assessment and accuracy, as mammography sensitivity is reduced to approximately 48 percent from an average of 98 percent 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." The solution delivers breast density measurements according to the American College of Radiology's BI-RADS reporting system.