U-Systems’ somo•v automated breast ultrasound system has been scheduled for review by the Radiological Devices Panel of the FDA on April 11.
U-Systems is seeking a breast cancer screening indication for the somo•v system. Currently, somo•v is FDA-cleared for diagnostic use as an adjunct to mammography, according to the Sunnyvale, Calif.-based ultrasound developer.
The somo•v system automates the breast ultrasound imaging process for the high-volume screening environment. Exams can be reviewed on the somo•Viewer 3D workstation.