New Device Approved for Screening Dense Breasts

The FDA recently announced that an ultrasound (U/S) device for breast cancer screening– the somo-v ABUS–has been approved for use in women with dense breasts.

Made by U-Systems of Sunnyvale, Calif, the product is to be used along with standard mammography in women with a negative mammogram and no breast cancer symptoms. It has a specially shaped transducer that automatically scans the entire breast in about 1 minute, producing several images for review, according to the FDA.

In a trial conducted by U-Systems, radiologists examined mammograms from 200 asymptomatic women with dense breasts, with and without supplementary U/S images from the somo-v ABUS device. Results indicated that use of the U/S images increased breast cancer detection by about 30%. Approximately 4% of results in the trial were false-positives.

Because previous breast intervention such as surgery or biopsy might alter the appearance of breast tissue on U/S, the agency said that women who had previously had such interventions would not generally be eligible for screening with the device.

For clinicians and technologists who plan to use the device, the FDA will require that U-Systems conduct training. The company must also distribute a manual that describes quality control tests that users should perform regularly.

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