Ultrasound developer U-Systems said that its somo.v automated breast ultrasound system (ABUS) will be reviewed by a U.S. Food and Drug Administration (FDA) advisory panel on April 11.
The review by the FDA's Radiological Devices Panel is the next step in the company's premarket approval (PMA) application for a breast cancer screening indication for somo.v, according to U-Systems. The system currently has been cleared for diagnostic use as an adjunct to mammography.
