The US Food and Drug Administration (US FDA) has approved 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.
Called the somo-v Automated Breast Ultrasound System (ABUS), it 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 clinical study in which board-certified radiologists were asked to review mammograms alone or in conjunction with somo-v ABUS images for 200 women with dense breasts and negative mammograms.
Biopsies were performed on masses detected with the somo-v ABUS to determine if they were cancer. 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.
“A physician may recommend additional screening using ultrasound, for women with dense breast tissue and a negative mammogram,” said Alberto Gutierrez, Director of the Office of In Vitro Diagnostic Device Evaluation and Safety at FDA’s Centre for Devices and Radiological Health. “The somo-v ABUS is a safe and effective breast ultrasound tool when such screening is recommended,” he added.
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.
As part of the approval, FDA has required that the manufacturer provide thorough training for physicians and technologists using the ABUS device, and that the manufacturer provide each facility with a manual clearly defining system tests required for initial, periodic, and yearly quality control measures.
The somo-v ABUS is marketed by Sunnyvale, Calif.-based U-Systems Inc.
EH News Bureau
- Advertisement -
