U-Systems has received a pre-market approvable (PMA) letter from the FDA for its somo•v Automated Breast Ultrasound (ABUS) system for breast cancer screening as an adjunct to mammography for asymptomatic women with dense breast tissue.
Using technology to automate the ultrasound imaging process, the U-Systems’ somo•v ABUS system was developed for the high-volume, breast cancer screening environment. The somo•VIEWer Advanced 3D Workstation enables review and archive of patient exams.
Final approval of the company’s PMA application for the system remains subject to satisfactory review and inspection of U-Systems manufacturing facilities, methods and controls. The company said it plans to work with the FDA to complete this final inspection.