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First digital mammography system approved

Image

January 31, 2000
Web posted at: 4:34 p.m. EST (2134 GMT)

WASHINGTON (CNN) -- The Food and Drug Administration Monday approved the first mammography system that produces digital images for use in the United States.

The Senographe 2000D is designed to generate digital mammographic images that can be used for screening and diagnosis of breast cancer and can be used as an alternative to traditional methods of mammography.

Clinical studies of digital mammography compared with analog or traditional mammography were found to have "comparable clinical performance" in screening and diagnosis of breast cancer.

The FDA said, from a patient's point of view, mammography with a digital system "is essentially the same" as with the traditional film/screen system."

The evidence so far does not show that the digital images are more helpful in finding cancer than the analog/film images," the FDA said. However, the FDA has said that the digital technology offers potential advantages over standard mammography:

  • Digital images can be stored and transferred electronically

  • Digital images can be manipulated to correct for under- or overexposure without having to take another mammogram.

  • Digital mammography has a large dynamic range that allows examination of all areas of the breast that analog systems sometimes have trouble with.

    "This is the single biggest advance in mammography in 30 years, and women throughout the United States now have access to a powerful new tool in the fight against breast cancer," said Jeff Immelt, President and CEO of GE Medical, the manufacturer of the Senographe 2000D.



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