FDA accepts U-Systems' PMA for ABUS

The U.S. Food and Drug Administration (FDA) has accepted ultrasound developer U-Systems' premarket approval (PMA) application for use of the firm's somo.v automated breast ultrasound (ABUS) system for breast cancer screening.

The somo.v ABUS system is currently cleared by the FDA for diagnostic use as an adjunct to mammography, U-Systems said.

The company gathered statistical data for the PMA submission from a clinical study, called somo-InSIGHT, conducted by the University of Chicago. The study is designed to evaluate whether digital mammography in combination with the automated breast ultrasound system is more sensitive than routine screening with mammography alone in detecting breast cancer in women with dense breast tissue. More than 16,000 women have enrolled in the study at multiple breast imaging centers nationwide, U-Systems said.