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
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.
AI-Initiated Recalls After Screening Mammography Demonstrate Higher PPV for Breast Cancer
March 18th 2025While recalls initiated by one of two reviewing radiologists after screening mammography were nearly 10 percent higher than recalls initiated by an AI software, the AI-initiated recalls had an 85 percent higher positive predictive value for breast cancer, according to a new study.
