GE Healthcare announced today the acquisition of the Sunnyvale, Calif.-based U-Systems, the manufacturer of somo-v Automated Breast Ultrasound System, the only U.S.-marketed ultrasound cleared to act as an adjunct to mammography screening for women with dense breasts. Terms of the deal weren't disclosed.

U-Systems received approval from the Food and Drug Administration for the device in September.

According to a statement from GE, somo-v Automated Breast Ultrasound System is the only system on the market approved in the U.S. for adjunct breast cancer screening in women who are asymptomatic with greater than 50 percent dense breast tissue and no prior breast interventions.
"In addition to digital mammography and breast MR, GE can now offer breast screening ultrasound technology to our customers to help in early detection--which provides for more treatment options," Tom Gentile, president and CEO of GE Healthcare Systems, said in a statement.

Studies have shown that women with dense breast tissue have an increased likelihood of cancer. Results from the first American College of Radiology Imaging Network's 6666 breast cancer trial, published in 2008, showed ultrasound with mammography found an additional 1.1 to 7.2 cancers per 1,000 high-risk women with dense breast tissue.

"Mammography is an effective tool at finding breast cancer, but it doesn't work equally well in everyone. Recently completed studies demonstrated with the addition of somo-v ABUS we find about 30 percent more cancers in women who have a normal mammogram, normal physical examination and dense breasts. For the more than 40 percent of women who have dense breasts, this is a significant advancement in their breast healthcare," said Dr. Rachel Brem, the principal investigator of a study examining whether full-field digital mammography along with the somo-v could improve breast cancer detection when compared to mammography alone in women with dense breasts.

An earlier study found women with dense breasts were not at increased risk of dying from cancer although they are more likely to get it.

Some states are now mandating that providers inform women receiving mammograms if they have dense breasts, and what types of options are available to serve as a supplemental screening.

In late September, California became the fifth state behind Virginia, New York, Connecticut and Texas to require providers to inform women about dense breast tissue.

Here's GE's promotional video about the technology:

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