FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857

FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.


T00-07					  Print Media: 301-827-6242
January 31, 2000                          
					  Consumer Inquiries: 888-INFO-FDA

FDA APPROVES FIRST DIGITAL MAMMOGRAPHY SYSTEM

FDA has approved the Senographe 2000D, the first mammography system that produces digital images on a solid state receptor instead of analog images on a radiographic film. Film/screen (analog) mammography along with physical examination and breast self-examination is the standard method for breast cancer screening in women. The following information may be used to answer questions:

The Senographe 2000D, made by General Electric Medical Systems, was approved on the basis of clinical data showing its safety and effectiveness and on the recommendation of FDA's Radiological Devices Panel. The study compared digital mammography films with analog mammography films of 625 women, 44 of whom had breast cancer. The digital and film/screen images were analyzed and evaluated by five qualified radiologists specializing in mammography and found to have comparable clinical performance in screening and diagnosis of breast cancer.

From the patient's point of view, mammography with a digital system is essentially the same as with the film/screen system. The radiologist will look at analog and digital films in the same way under this approval.

The evidence presented so far does not show that the digital images are more helpful in finding cancer than the analog/film images. The digital technology, however, offers several potential advantages over the standard use of radiographic film. Unlike images on radiographic film, digital images:

can be stored and transferred electronically, which facilitates their quick and easy retrieval as well as remote evaluation by distant specialists;
can be manipulated to correct for under- or over-exposure without the necessity of taking another mammogram;
have a large dynamic range that allows examination of all areas of the breast, despite their varying density. The limited dynamic range of the film screen systems sometimes requires additional exposures at different settings to reveal very high or very low density areas of the breast.

For the immediate future, digital mammography may only be used in facilities certified to practice film/screen mammography.

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FDA TALK PAPER

FDA APPROVES FIRST DIGITAL MAMMOGRAPHY SYSTEM

FDA
TALK PAPER