FDA Approves First Breast Ultrasound Imaging System For Dense Breast Tissue

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The 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.

The National Cancer Institute estimates that about 40 percent of women undergoing screening mammography have dense breasts. Mammograms of dense breasts can be difficult to interpret as fibroglandular breast tissue and tumors both appear as solid white areas on mammograms.

Ultrasound imaging has been shown to be capable of detecting small masses in dense breasts. During an ultrasound exam, a transducer device directs high-frequency sounds waves at the portion of the body being examined. Software analyzes the differences in how the sound waves are reflected off different tissues and back to the transducer to create an image a physician can review for abnormalities.

The specially shaped transducer of the somo-v Automated Breast Ultrasound System (ABUS) can automatically scan the entire breast in about one minute to produce several images for review. The FDA reviewed results from a clinical study in which board-certified radiologists reviewed 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 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.