FDA Panel Meeting Scheduled for U-Systems’ Automated Breast Ultrasound (ABUS) System

SUNNYVALE, Calif.--(BUSINESS WIRE)--U-Systems, the leader in automated breast ultrasound, today announced the somo•v® Automated Breast Ultrasound (ABUS) system has been scheduled for review by the Radiological Devices Panel of the U.S. Food & Drug Administration (FDA) on April 11, 2012. The FDA Advisory Panel review is the next step in U-Systems’ premarket approval (PMA) application seeking a breast cancer screening indication for the somo•v ABUS system. The somo•v ABUS system is currently FDA-cleared for diagnostic use as an adjunct to mammography.