U-Systems, from Sunnyvale, California, has received approval of the European authorities for its somo•v automated breast ultrasound (ABUS) system as an adjunct to mammography for screening asymptomatic women for breast cancer. The system works by positioning a sheer membrane firmly on the breast after application of a conductive gel. It then automatically images the whole breast after which images can be rendered and reviewed in 3D. The complete field of view covers 15cm x 17cm x 5.0cm. The machine both has a high center-frequency enabling high resolutions and ultra broadband characteristics for optimal contrast. Scanning takes approximately one minute, with usually three scans being obtained from different angles. The system is not meant as a replacement of mammography for screening, but rather as an adjunct in patients with dense breast tissue to detect small tumors. A large trial, the SOMO·INSIGHT Clinical Study, is currently underway in the United States to determine whether digital mammography in combination with the somo•v Automated Breast Ultrasound system or a routine screening mammogram alone is more sensitive in detecting breast cancer in women with greater than fifty percent dense breast tissue. Up to 20,000 patients will be enrolled in the study.
Press release: U-Systems Receives Approval for Ultrasound Breast Cancer Screening…
Product page: U-Systems
Study website: Somos Insight study