Mammograms Go Digital: FDA Approves New System
Jan. 31, 2000 (Washington) -- In what is being hailed as a landmark development for women's health care, the FDA approved GE Medical Systems' Senographe 2000, the world's first digital mammography system for the diagnosis of breast cancer.
This device may significantly improve the diagnosis of breast cancer, and it is now also the first mammography system in over two decades to establish its safety and efficacy in clinical trials, Capt. Jerry Thomas, MSC, USN, tells WebMD. "Ultimately, thanks to this approval, what will we may now see is more use of computer-assisted devices that will help professionals make a better diagnosis," says Thomas, who is chief of radiological physics at the Uniformed Services University of the Health Sciences.
At present, though, the digitally captured image must still be transferred onto film prior to being "read" by a radiologist. In addition, says Dan Schultz, MD, acting director of the FDA's Division of Reproductive, Abdominal, and Radiological Devices, "As of now, we have no data to say that it can outperform [conventional] film, although that's not to say it won't be forthcoming."
But even without that data, digital mammography still offers several distinct advantages over the film-based systems, Luz Venta, MD, director of the Lynn Sage Breast Center at Northwestern University, tells WebMD. Least among those, she says, is the ability to store the image in a format that will allow the image to be shared among networked specialists. "This feature probably will not make a big impact initially, but as it becomes more and more widely used, it will give physicians a chance to more easily consult each other," she says.
In the future, she adds, that advantage will be eclipsed by the ability to read the image directly off a computer monitor. This ability, she says, will allow qualified radiologists to adjust the contrast, exposure, and density of the image to see both the fatty and dense areas of the breast without printing and reviewing five or more separate images.
It eventually also will allow radiologists to interpret the data from 3-D images, says Thomas, who currently is conducting an independent study to establish the effectiveness of monitor-based images. "Film images are not a bad means of diagnosis, but the digital image could prove to be a far more optimal image than those printed on film," he says.
Film images presently reveal an estimated 80% of all breast cancers, which makes them quite accurate, says Schultz. But despite whether this device is more effective, he says, the other distinct advantage to the approval of this latest device is the publicity it will receive. "Anytime you have any publicity, there is potential for a bounce, and hopefully, that bounce will stimulate women to have any sort of mammography," he says.