The FDA approved the use of R2's mammography computer aided detection technology with Fischer's SenoScan TrueView Digital Scanning Mammography system.
Computer aided detection is used by increasing numbers of radiologists as "a second pair of eyes" when reading a woman's mammogram. Analogous to a spellchecker system on a personal computer, this technology has the potential to detect findings that might otherwise be overlooked during the review process, thus increasing cancer detection. Computer aided detection technology also is especially effective in identifying calcifications, some of which can be cancerous. To date, nearly eight million women have had their mammograms interpreted with the aid of the R2 ImageChecker computer aided detection system, and more than 1,000 ImageChecker systems are installed worldwide.
Under an existing development and marketing agreement, Fischer Imaging will integrate R2's computer aided detection technology into its SenoScan TrueView Digital Scanning Mammography System and have distribution rights to the integrated system. R2 Technology's ImageChecker DM system, which received FDA approval in September 2003, also will support computer aided detection analysis of digital images acquired on the SenoScan system. The ImageChecker DM System will be distributed directly by R2 and by Fischer in conjunction with its traditional film-based mammography products.
"We are pleased to be able to offer radiologists the most innovative technology available to assist in the early detection of breast cancer," said Harris Ravine, chief executive officer for Fischer Imaging. "Since we began working with R2 Technology on the integration of computer aided detection with the SenoScan system, we've felt this partnership would result in a world class solution offering a powerful tool in the fight against breast cancer."
Recently the American Cancer Society recognized the benefits of computer aided detection as a new technology for breast cancer screening in women of average risk. The updated guidelines state: " ... that computer aided detection systems may aid the average radiologist by substantially improving detection of early stage malignancies with no more than a proportionate increase in recall rate."
In 1998, the ImageChecker computer aided detection system was the first FDA-approved system for use with film-based screening mammography to assist radiologists in minimizing false negative readings. The ImageChecker system also was the first computer aided detection system approved by the FDA for use with digital mammography. Recently, R2 received FDA approval for the ImageChecker DM, an integrated solution to support computer aided detection processing for both analog and digital mammography in a single Dual Mode (DM) unit. Clinical trials demonstrated that use of the ImageChecker computer aided detection system could result in earlier detection of up to 23.4 percent of the cancers currently detected with screening mammography in those women who had a prior screening mammogram nine-24 months earlier.
Fischer Imaging's SenoScan system incorporates the company's patented slot scanning detector, providing the highest resolution available in the digital mammography industry and up to 60 percent less radiation dose as compared to other mammography systems -- film or digital.
The SenoScan system is the only digital mammography system with a field- of-view large enough to accommodate almost all sizes of breasts without repositioning the patient. The system is designed with an open architecture to accommodate new technological developments such as computer aided detection software, tomosynthesis (3-D imaging) and contrast subtraction mammography.
"R2 pioneered the use of computer aided detection with film mammography. With the recent approval of the ImageChecker DM and clearance of computer aided detection for use with the Fischer FFDM system, we continue to lead the transition to digital mammography," said Michael S. Klein, president and CEO of R2 Technology. "During this transition, we will continue to innovate in order to address the new, mixed mammography environment by supporting both analog and digital mammography. And, as always, our primary goal remains improving the early detection of breast cancer."
Fischer Imaging designs, manufactures, and markets specialty digital mammography and general-purpose x-ray imaging systems for the diagnosis and treatment of disease.
R2 Technology develops and commercializes computer-aided detection, an innovative technology that assists radiologists in the early detection of breast cancer and other abnormalities.