iCAD gains FDA clearance for AI software that calculates breast density

iCAD announced that its PowerLook Density Assessment 3.4 solution has gained FDA clearance. 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.

“Since implementing PowerLook Density Assessment, our radiologists have been able to provide more consistent breast density results for our patients during screenings,” Beth Ingram, MD, a radiologist at Reid Health in Richmond, Indiana, said in the same statement. “We must consider many aspects of each patient’s case at once, but PowerLook Density Assessment allows us to focus on our primary goal of finding breast cancer.”