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FRIDAY, Feb. 11 (HealthDay News) -- The first three-dimensional mammography system has been approved by the U.S. Food and Drug Administration.
The Selenia Dimensions System produces 3-D and 2-D X-ray images of the breast to help doctors in the early detection of breast cancer. With conventional 2-D mammography systems, about 10 percent of patients require additional testing to determine whether abnormalities are cancerous, the FDA said in a news release.
Nearly 40 million mammograms are done each year in the United States, the agency said. The U.S. National Cancer Institute recommends the procedure every one to two years for women age 40 and older.
In clinical testing of the newly approved system, radiologists showed a 7 percent improvement in the ability to distinguish cancerous and non-cancerous abnormalities compared with conventional mammography systems, the FDA said.
Noting that the Selenia system exposed women to about double the amount of radiation of a conventional mammogram, the agency said fewer women had to be re-tested with the new system, sparing them exposure to additional radiation.
The Selenia system is produced by Holgoic Inc., based in Bedford, Mass.
The FDA has more about this approval.
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