A new device for breast cancer screening has been approved for women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer. The FDA has approved the somo-v Automated Breast Ultrasound System (ABUS), the first ultrasound device for use in combination with a standard mammography of dense breast tissue.
The specially shaped transducer of the somo-v ABUS can automatically scan the entire breast in about 1 minute to produce several images for review.
According to the National Cancer Institute, an estimated 40% of women undergoing screening mammography have dense breasts. Mammograms of dense breasts can be difficult to interpret. Dense breast tissue may obscure smaller tumors and potentially delay detection of breast cancer. As a result, women with dense breast tissue face an increased risk of breast cancer, and their cancer is often detected at a more advanced stage.
As part of the approval process, the FDA reviewed results from a clinical study involving 200 women with dense breasts and negative mammograms. For the study, board-certified radiologists reviewed mammograms alone and in conjunction with somo-v ABUS images.
Biopsies were performed on masses detected with the somo-v ABUS. Study results show a statistically significant increase in breast cancer detection when ABUS images were reviewed in conjunction with mammograms, as compared to mammograms alone.
“A physician may recommend additional screening using ultrasound, for women with dense breast tissue and a negative mammogram,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostic Device Evaluation and Safety at FDA’s Center for Devices and Radiological Health. “The somo-v ABUS is a safe and effective breast ultrasound tool when such screening is recommended.”
Because a prior surgery or biopsy might alter the appearance of breast tissue in an ultrasound image, the somo-v ABUS is approved for use in women who have not had previous clinical breast intervention.
Source: FDA.