New Screening Device for Dense Breasts Approved by FDA

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On Sept. 18, 2012, the U.S. Food and Drug Administration (FDA) approved the somo-v automated breast ultrasound system (ABUS), an ultrasound screening device specifically designed for women with dense breasts.

The ultrasound device will be used in combination with regular mammograms for women with dense breasts who have negative mammogram results and no breast cancer symptoms.

Read a media release about the new device from the FDA.

Dense breasts have less fatty tissue and more non-fatty tissue compared to breasts that aren’t dense. Doctors can tell if breasts are dense by the way they look on a mammogram.

Research has shown that dense breasts:

  • can be 6 times more likely to develop cancer
  • can be harder for mammograms to detect cancer in; breast cancers (which aren’t fatty) are easier to see on a mammogram when they’re surrounded by fatty tissue

Research also has shown that adding ultrasound to annual mammograms improves breast cancer detection in women with dense breasts.

The soma-v ABUS device automatically scans the entire breast in about a minute and then creates several images for the radiologist to review.

The device already was approved in Europe and Canada for breast cancer screening (along with mammograms) in women with dense breasts.

The FDA approval is based on research that showed using somo-v ABUS images along with mammogram images improved breast cancer detection by about 30% in women with dense breasts.

It’s important to know that screening with the somo-v ABUS device isn’t recommended for women who’ve had breast surgery, including a breast biopsy, because the surgery may alter the way the breast tissue looks in an ultrasound image.

The FDA approval also requires the company that makes the somo-v ABUS device to offer thorough training to doctors and radiology technicians on how to use the device.

Stay tuned to Breastcancer.org’s Research News for the latest information on new techniques to detect and treat breast cancer.

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