FDA approves somo-v Automated Breast Ultra Sound System for dense breast imaging - 22-Sep-2012

The FDA on 18 September 2012 approved the somo-v Automated Breast Ultrasound System (ABUS) from U-Systems Inc., which is the first ultrasound device for use in combination with a standard mammography in women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer.

Dense breasts have a high amount of connective and glandular tissue (fibroglandular tissue) compared with less-dense breasts, which have a high amount of fatty tissue. A physician determines if a woman has dense breast tissue with a mammography exam. Mammography is a low-dose X-ray imaging method of the breast. However, mammograms of dense breasts can be difficult to interpret. The specially shaped transducer of the somo-v Automated Breast Ultrasound System can automatically scan the entire breast in about one minute to produce several images for review.

The somo-v ABUS is approved for use in women who have not had previous clinical breast intervention, such as a surgery or biopsy, since this might alter the appearance of breast tissue in an ultrasound image.The somo.v is currently FDA 510(k)-cleared for adjunctive diagnostic use with mammography.

The somo-v ABUS system is the only ultrasound device approved for breast cancer screening in the United States, Canada and 27 European Union countries as an adjunct to mammography for asymptomatic women with dense breast tissue.