Entries in Device (1)


FDA Approves 1st 3-D Mammography Device

Photo Courtesy - Getty Images(WASHINGTON) -- On Friday, the Food and Drug Administration approved the first X-ray mammography device that will produce three-dimensional images of the breast for cancer screening and diagnosis.

The Selenia Dimensions System is an alternative to the conventional two-dimensional one, which causes about 10 percent of women to undergo additional screening after an initial test, only to find that apparent abnormalities were, in fact, noncancerous.

The Selenia Dimensions System will be capable of producing both 2D and 3D images and will help physicians "more accurately detect and diagnose breast cancer," the FDA stated in a release.

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

The National Cancer Institutes suggests that women over the age of 40 have a mammogram every one-to-two years.

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