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WASHINGTON, Feb. 12 (UPI) -- The first three-dimensional X-ray mammography machine will significantly advance breast cancer diagnosis, the U.S. Food and Drug Administration says.
The FDA approved the Selenia Dimensions System Friday, Chicago Tribune reported.
The device "could significantly enhance existing diagnosis and treatment approaches," said Jeffrey Shuren, chief of the FDA office of medical devices.
Regulators hope the 3-D system will cut the number of women requiring a second round of testing after initial mammograms show possible cancer.
The FDA reviewed two studies in which radiologists examined 2-D and 3-D images from more than 300 mammographies. In both studies, radiologists distinguished between cancerous and non-cancerous cases by 7 percent more than by viewing 2-D images alone.
The National Cancer Institute recommends a mammogram every one to two years for women 40 and older. Nearly 40 million are performed yearly.
The Selenia Dimensions System is marketed by Hologic Inc. of Bedford, Mass.
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