U-Systems Inc. plans an immediate U.S. market launch of its somo-v automated breast ultrasound (ABUS) system for breast cancer screening following PMA approval announced Sept. 18. Somo-v was 510(k)-cleared in 2005 for diagnostic use as an adjunct to x-ray mammography; the PMA is for breast cancer detection in asymptomatic dense-breasted women who have not had a previous clinical breast intervention following a negative mammogram screening. The expanded indication makes somo-v the first ultrasound device available in the U.S. with a breast cancer screening indication, according to the company.
Increased use of the system is expected to be aided by states which have passed so-called breast density notification laws,...