FDA Panel Recommends Approval for U-Systems’ Breast Cancer Screening Tool for Women with Dense Breasts

GAITHERSBURG, Md., Apr 11, 2012 (BUSINESS WIRE) -- U-Systems, the leader in automated breast ultrasound, today announced that the U.S. Food and Drug Administration’s (FDA) Radiological Devices Panel of the Medical Devices Advisory Committee recommended approval of the somo*v® Automated Breast Ultrasound (ABUS) system. U-Systems’ premarket approval (PMA) application is seeking a breast cancer screening indication for the somo*v ABUS system, which is currently FDA-cleared for diagnostic use as an adjunct to mammography.

If final PMA approval is granted, the somo*v ABUS system would be the only ultrasound device in the United States approved for breast cancer screening as an adjunct to mammography for asymptomatic women with dense breast tissue. Although the FDA is not bound by the recommendations of its advisory committees, it generally follows their advice.

“With the positive FDA panel review of the somo*v for breast cancer screening, we now have the opportunity to integrate 3D automated breast ultrasound screening into clinical practice, which will enable us to find previously undetectable cancers,” said Rachel Brem, M.D., Director of Breast Imaging at The George Washington University Hospital, Washington D.C. “Mammography is an effective tool at finding breast cancer, but it doesn’t work equally well in everyone. In women with dense breasts, we can’t see over a third of breast cancers, so we need other technologies, other approaches.

source: Market Watch