FDA Approves First 3D Mammogram Device02/14/11
FRIDAY, Feb. 11 (HealthDay News) -- The U.S. Food and Drug
Administration approved on Friday the first X-ray mammography
device that provides three-dimensional images of the breast for
cancer screening and diagnosis.
The Selenia Dimensions System, an upgrade to Massachusetts-based
Hologic Inc.'s FDA-approved two-dimensional 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 breast cancer, the
FDA said in a news release.
"Physicians can now access this unique and innovative 3-D technology that could significantly enhance existing diagnosis and treatment approaches," said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.
A mammogram is a low-dose X-ray of the breast and is considered
the best tool for early detection of breast cancer. But, with
conventional two-dimensional imaging, an estimated 10 percent of
women must endure additional testing because an initial screening
exam found abnormalities that were later determined to be
noncancerous, the agency said.
The combined use of the Selenia's 2-D and 3-D images roughly
doubled the amount of radiation a patient received. But, it
improved accuracy, decreasing the number of women called back for
additional testing, the FDA said. The agency added that there is
uncertainty about radiation risk estimates. However, the increase
in cancer risk from having both a 2-D and 3-D exam is expected to
be less than 1.5 percent compared to the natural cancer incidence,
and less than 1 percent compared to the risk from conventional 2-D
The U.S. National Cancer Institute recommends that women ages 40
and older have a mammogram every one to two years. Nearly 40
million mammograms are performed each year in the United
As part of the approval process, the FDA reviewed results from
two studies where board-certified radiologists were asked to review
two-dimensional and three-dimensional images from more than 300
mammography exams. In both studies, the radiologists viewing both
the 2-D and 3-D images realized a 7 percent improvement in their
ability to distinguish between cancerous and non-cancerous cases,
compared to viewing 2-D images alone, the agency said.
According to the NCI, nearly 200,000 women will be diagnosed
with breast cancer this year, and 1 in 8 women will face a
diagnosis of breast cancer sometime during their lifetime. However,
there is a 98 percent survival rate when breast cancer is detected
early and still localized to the breast.
To learn more about mammograms, visit the
U.S. National Library of Medicine.
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