SenoScan clears FDA

Customers shopping for full-field digital mammography systems have another product to consider. The FDA has cleared Fischer Imaging’s SenoScan for sale in the U.S. In making the announcement Sept. 25, Fischer executives predicted that a large portion of the currently installed 30,000 screen-film mammography systems would eventually be replaced by digital systems, with the conversion rate reaching as high as 1500 systems per year by 2007. So far, only Fischer and GE Medical Systems have been cleared to sell such products. Prior to the FDA decision, Fischer announced the sale of five SenoScans to research institutions participating in a $26 million study sponsored by the National Cancer Institute to determine the accuracy of digital mammography. SenoScan, which is built around a slot scanning digital detector, can support computer-aided detection software, tomosynthesis involving 3-D imaging, and contrast subtraction mammography.