The University of Chicago has completed a reader study to evaluate the somo.v automated breast ultrasound (ABUS) system from U-Systems for detecting breast cancer in women with dense breast tissue.
The primary objective of the multireader, multicase study was to determine the effect of somo.v on the performance of interpreting physicians when used in combination with mammography as a screening modality for asymptomatic women with dense breast tissue, according to principal investigator and professor of radiology Maryellen Giger, PhD.
Cases in the study were collected under the ongoing somo-InSIGHT clinical study, which is recruiting up to 20,000 women at multiple breast imaging centers in the U.S. To date, more than 12,000 women have participated in the clinical study, according to the Sunnyvale, CA-based company.
U-Systems will use data from the reader study as the basis for its premarket approval (PMA) submission of somo.v to the U.S. Food and Drug Administration (FDA).
