In a move aimed to help health care providers detect smaller tumors, the U.S. Food and Drug Administration Tuesday approved the first breast ultrasound imaging system for dense breast tissue.
The ultrasound device - called somo-v Automated Breast Ultrasound System (ABUS) - is to be used along with a standard mammography in women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer. The somo-v ABUS is marketed by Sunnyvale, California-based U-Systems Inc.
Dense breasts have a high amount of connective and glandular tissue and a mammography exam helps a physician to determine if a woman has dense breast tissue. However, mammography, a low-dose X-ray imaging method of the breast, can be difficult to interpret among women with dense breasts.
Ultrasound imaging meanwhile has been shown to be capable of detecting small masses in dense breasts. The specially shaped transducer of the somo-v ABUS can automatically scan the entire breast in about one minute to produce several images for review.
As part of the approval process, the FDA reviewed results from a study in which radiologists were asked to review mammograms alone or in conjunction with somo-v ABUS images for 200 women with dense breasts and negative mammograms.
The results show a statistically significant increase in breast cancer detection when ABUS images were reviewed in conjunction with mammograms, as compared to mammograms alone.
The FDA said that 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.
According to the National Cancer Institute, about 40 percent of women undergoing screening mammography have dense breasts. These women have an increased risk of breast cancer, with detection usually at a more advanced and difficult to treat stage.
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