FDA approves computer-aided detection for digital mammography.

2004 JAN 1 - (NewsRx.com & NewsRx.net) -- Fischer Imaging Corporation (FIMG) and R2 Technology, Inc., announced that approval has been granted by the U.S. Food and Drug Administration (FDA) for the use of R2's proprietary mammography CAD technology with Fischer's SenoScan TrueView Digital Scanning Mammography system.

CAD is used by increasing numbers of radiologists as "a second pair of eyes" when reading a woman's mammogram. Analogous to a spell checker 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. CAD 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 CAD system, and more than 1000 ImageChecker systems are installed worldwide.

Under an existing development and marketing agreement, Fischer Imaging will integrate R2's CAD 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 CAD 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 CAD 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 CAD as a new technology for breast cancer screening in women of average risk. The updated guidelines state: " ... that CAD systems may aid the ...