FDA Panel Backs First Digital Mammography System
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.