Skip to content
My WebMD Sign In, Sign Up

Breast Cancer Health Center

Font Size

FDA Panel Backs First Digital Mammography System


WebMD Health News

Dec. 17, 1999 (Rockville, Md.) -- An FDA advisory panel unanimously backed approval for what stands to be the first available digital device for breast cancer screening and diagnosis. GE Medical Systems' Senographe 2000D is a "full-field" digital mammography system.

Brian Garra, MD, chairman of FDA's Radiological Devices Panel, tells WebMD, "We have enough data to convincingly demonstrate that the digital [system] is at least as good [as traditional mammography] and will probably advance well beyond."

Current mammography practice is centered around analog film images, but digital technology permits speedier turnaround, easier storage, and physician manipulation of images.

According to the FDA, about 25 million women are screened for breast cancer each year, with about 180,000 cancers detected.

"We're seeing now the collapse of the old film-based system. It served us well for 60 or 70 years," Garra says. "[Digital technology] will take mammography from the 75% accuracy that we're seeing routinely these days to maybe 85% or 90%."

Two GE studies, each involving over 600 women, compared mammography readings from both film and digital systems. Investigators found the technologies comparable for the detection of cancer, with the new technology requiring slightly fewer recalls. A separate analysis found comparability between the two technologies' images of tissue at the chest wall, while the digital application showed a slight advantage in the visibility of tissue at the skin line.

But the FDA raised a few concerns. Agency reviewer William Sacks, MD, noted that the relatively low sample sizes the company presented raised the statistical possibility that the digital technology could be 10% less sensitive than current applications in detecting cancers -- or 7% more sensitive.

The FDA also said it was concerned that the study may have favored women with larger or more advanced cancers, since it drew from a population that included those already screened. But well more than half of the cancers the digital device detected were early stage -- "type 0" and "type 1" -- exceeding federal clinical guidelines.

Although the FDA wants the company to conduct a post-marketing study to increase its confidence in the device, the committee thought that that could be a waste of time and money. Panel member Steven Harms, MD, said, "I have a great deal of concern whether this is worth the effort," since, he said, research has already demonstrated digital-traditional film equivalence.

Company officials said they expected the FDA would approve the system "very early" next year.

To meet regulatory guidelines for testing, GE's clinical research compared "hard-copy" digital images -- those printed out onto film -- to the traditional film images. So the firm must still develop and conduct a study of the effectiveness of the device in "soft-copy" applications -- and sell the FDA on its findings.

Soft-copy images are those that appear only on a computer screen. That application permits a radiologist to use a high-resolution monitor and make adjustments for contrast and light intensity. The advisory panel unanimously urged the FDA to expedite approval of the soft-copy use.

GE says that it spent 11 years and more than $100 million to develop the technology. Several other major device firms have digital screening tools in development, including Siemens Medical Systems, Fischer Imaging, Trex, and Fuji Medical.

FDA usually follows, but is not bound by, the recommendations of its advisory panels.

Today on WebMD

Breast Cancer Overview
From self-exams and biopsies to reconstruction, we’ve got you covered.
Dealing with breast cancer
Get answers to your questions.
 
woman having mammogram
Experts don’t agree on all fronts, but you can be your own advocate.
woman undergoing breast cancer test
Many women worry. But the truth? Most abnormalities aren’t breast cancer.
 
Breast Cancer Treatments Improving
VIDEO
Resolved To Quit Smoking
SLIDESHOW
 
Woman getting mammogram
Article
Screening Tests for Women
SLIDESHOW
 
ovarian cancer overview slideshow
SLIDESHOW
serious woman
Article
 
what is your cancer risk
HEALTH CHECK
10 Ways to Revitalize Slideshow
SLIDESHOW