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FDA Approves the First 3-D Imaging Mammography Device

Posted on the 22 April 2011 by Jean Campbell

This past February,the U.S. Food and Drug Administration approved the Selenia Dimensions System, the first mammography device that provides three-dimensional (3-D) images of the breast for screening and diagnosis of breast cancer.

Why is this such an important step in breast cancer screening? Until now, given the limitations of conventional two-dimensional (2-D) imaging, about 10 percent of women have to undergo additional testing after the initial screening exam for abnormalities that are later found to be noncancerous.

The Selenia Dimensions System, an upgrade to Hologic’s existing FDA-approved 2-D system, can provide 2-D and 3-D X-ray images of the breasts. The 3-D images may help physicians more accurately detect and diagnose.


“Physicians can now access this unique and innovative 3-D technology that could significantly enhance existing diagnosis and treatment approaches,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The National Cancer Institute recommends women ages 40 + years go for an annual mammography. Nearly 40 million mammograms are performed each year in the United States.

Part of the approval process by the FDA involved  reviewing results from two studies where board-certified radiologists were asked to review 2-D and 3-D images from more than 300 screenings. In both studies, radiologists viewing both the 2-D and 3-D images obtained a 7 percent improvement in their ability to distinguish between cancerous and non-cancerous cases as compared to viewing 2-D images alone.

While the combination of the Selenia’s 2-D and 3-D images approximately doubled the radiation dose the patient received, it improved the accuracy with which radiologists detected cancers, decreasing the number of women recalled for a diagnostic workup.

Given the incidence of breast cancer in the U.S. (1 in 8 women) and that there is a 98 percent survival rate when breast cancer is caught early and still localized to the breast this newer, more accurate screening system is welcome news.

SOURCE U.S. Food and Drug Administration

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