Automated breast ultrasound (ABUS) developer U-Systems has received a premarket approval (PMA) letter from the U.S. Food and Drug Administration (FDA) for its somo.v ABUS system.
The scanner may now be used for breast cancer screening as an adjunct to a mammography exam for asymptomatic women with dense breast tissue.
Final approval of the PMA application remains subject to satisfactory review and inspection of U-Systems' manufacturing facilities, methods, and controls, the company said.
