Automated Ultrasound for Women With Dense Breasts Approved by FDA Panel

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On April 11, 2012, a U.S. Food and Drug Administration (FDA) expert panel recommended that an automated ultrasound device be approved for breast cancer screening in women with dense breasts.

The automated ultrasound device is called somo*v automated breast ultrasound system (ABUS) and was specifically designed to detect cancer in women with dense breasts.

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. Ultrasound technology designed to find breast cancer in dense breasts could improve the usefulness of ultrasound for this type of screening.

The soma*v ABUS ultrasound device already is FDA-approved to help diagnose cancer in women with a breast abnormality that's suspected to be breast cancer. The FDA expert panel has now recommended expanding soma*v ABUS' use to include screening (along with mammograms).

The FDA panel did caution that this ultrasound should probably only be used to screen women with dense breasts who haven't had a breast biopsy or breast cancer surgery. Soma*v ABUS ultrasound already is approved in Europe and Canada for breast cancer screening (along with screening mammograms) in women with dense breasts.

The FDA doesn't have to follow the recommendation of the panel, but it usually does.

Stay tuned to Research News for updates on the approval process of soma*v ABUS for breast cancer screening in women with dense breasts.

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