FDA Approves Ultrasound Companion to Mammograms

In April this year, the U.S. Food and Drug Administration (FDA) Radiological Devices Panel of the Medical Devices Advisory Committee recommended approval of U-Systems Inc.’s Somo-V Automated Breast Ultrasound (ABUS) system. The ultrasound system now has been approved by the FDA for use in women with dense breast tissue.

The Somo-V Automated Breast Ultrasound system. Photo courtesy of U-Systems Inc.

According to Ron Ho, president and CEO of the device manufacturer, at least 40 percent of women in the United States have dense breast tissue.

The ABUS system is meant to be used alongside a standard mammography in women with a negative mammogram and no breast cancer symptoms. According to the FDA, the transducer on the device is able to scan the entire breast in approximately one minute, producing several images for review.

Women who have had a previous breast intervention such as surgery or biopsy generally would not be eligible for screening with the device, the agency wrote, “since this might alter the appearance of breast tissue in an ultrasound image.”

It is the only ultrasound device approved for breast cancer screening in the United States, Canada and 27 European Union countries as an adjunct to mammography for asymptomatic women with dense breast tissue, U-Systems claims.

Dense breast tissue not only increases the risk of breast cancer up to four to six times but also makes cancer more difficult to detect using mammography, according to multiple large studies. One study, published in the New England Journal of Medicine, showed 35 percent of breast cancer goes undetected by mammography in women with dense breasts, as density masks the appearance of tumors.

“Enabling radiologists to use the information obtained from mammography and integrate that with the information obtained with ultrasound leverages the potential of ABUS in a screening environment to find the 30 percent additional cancers that would not have been found with mammography alone,” said Ho. “Research shows that ABUS can help find cancer in women with dense breasts, and that the cancers are smaller and early stage. With formal approval, we are moving rapidly from development to commercialization and look forward to making the Somo-V ABUS system more widely available across the United States.”

The FDA is requiring that U-Systems conduct training for clinicians and technology specialists who will use the device. The company also must distribute a manual that describes quality control tests that users should perform regularly.

U-Systems manufactures and markets ultrasound technology geared toward early cancer detection.
The company is based in Sunnyvale, Calif.

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