Digital Mammography Receives FDA Clearance

WAUKESHA, Wis., April 22 -- The US Food and Drug Administration (FDA) has approved the use of R2 Technology Inc.'s mammography CAD technology with GE Medical System's Senographe full-field digital mammography system.

Computer-aided detection (CAD) 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.

R2's ImageChecker system was originally approved by the FDA in 1998 for use with film-based screening mammography to assist radiologists in minimizing false-negative readings, and in 2001 the FDA expanded approval to include use with diagnostic mammograms.