First 3-D Mammography Test Cleared02/11/11
FRIDAY, Feb. 11 (HealthDay News) -- The first three-dimensional
mammography system has been approved by the U.S. Food and Drug
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 if
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 40 and
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
The FDA has more about
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