LIVERMORE, Calif. – A Denver, Colo. company that worked with Lawrence Livermore National Laboratory researchers announced Tuesday that it has received Food & Drug Administration approval for its digital mammography system.
Fischer Imaging Corporation partnered with LLNL from 1993 to 1996 on digital mammography work under a Cooperative Research & Development Agreement with the Lab’s Engineering Directorate. While traditional mammography technology uses film to recLord the X-ray image, Fischer’s new SenoScan digital mammography system records the image electronically.
Digital breast imaging opens the door for many changes in the practice of mammography, in the view of Livermore mechanical engineer Clint Logan, who headed the Laboratory’s collaboration with Fischer.
With this technology, images can be acquired at one location and then be rapidly transmitted by computer to another site for interpretation.
"One advantage of digital mammography," notes Logan, "is that rapid collaboration with experts at other locations becomes possible."
Probably the most important feature, however, is that computers can now be employed to aid in the diagnosis or evaluation of a digital image, Logan says.
Digital "copies" have the same high fidelity as original images. Image parameters such as contrast and brightness become display adjustments, not fixed by film chemistry and exposure.In its application to the FDA, Fischer submitted the results of a 1,500-patient study conducted at UC-San Francisco, the University of North Carolina and other medical facilities over the course of three years. The study compared SenoScan results with those of traditional mammography.
The FDA approval of SenoScan means, in effect, the federal agency has found the digital system to be safe and effective for use in the same clinical applications as traditional mammography.
With FDA approval, SenoScan becomes available for regular clinical use to treat patients. Previously, it could have only been used in a research setting.
Morgan W. Nields, chairman of Fischer Imaging, noted, "We are delighted to have received FDA approval for SenoScan and expect to immediately begin the process of providing this technology for the millions of women who employ mammography for early detection of breast cancer.
"SenoScan is a powerful tool for both screening mammography and for more detailed diagnostic studies. Many people contributed to bringing SenoScan to fruition, including university researchers, Lawrence Livermore National Laboratory and especially Fischer’s own staff." Fischer President and Chief Executive Officer Lou Rivelli stated, "Fischer invested a decade of development and over $30 million to bring SenoScan to market. It will be our flagship product. The availability of SenoScan has been widely anticipated and we expect to begin commercial shipments later this year." LLNL’s interest in digital mammography was fueled by work performed for the nation’s Ballistic Missile Defense Program, specifically the X-Ray Laser Program.
When the U.S. ended its X-ray Laser Program, the Livermore team turned to digital mammography as a possible area to apply analysis tools and expertise that had been developed for material characterization for the X-ray laser.
LLNL’s Logan recalls, "In 1993, Fischer had developed a small-field digital breast imager for image-guided core biopsy. Our ideas for screening mammography matched their interests and the LLNL team very quickly became a part of Fischer’s team.
"We recognized that we could design a machine that requires less X-ray dose for larger breasts than conventional mammography. Fischer made this a design goal from the beginning. Fischer also chose to accommodate a larger field of view than the other FDA cleared system.
This virtually eliminates the need for multiple exposures to cover the entire breast." Logan continued, "We learned a lot working with Fischer. We last worked on SenoScan in 1996, but have followed Fischer’s progress in gaining FDA approval. This feels like a tremendous victory." In addition to Logan, another key LLNL researcher who contributed to the Fischer-Livermore collaboration was electronics engineer Jose M. Hernandez. Hernandez performed the computer programming to simulate the transport of radiation through human tissue.