Fischer system heads toward FDA filing

Fischer Imaging of Denver is collecting the clinical data to supporta 510(k) application for its SenoScan full-view digital mammographyscanner. Fischer has placed beta SenoScan units at Brooke ArmyMedical Center in Fort Sam Houston, TX, Thomas Jefferson Universityin Philadelphia, and the University of California at San Francisco.

Fischer and other companies developing full-field systems willbe able to go the 510(k) route rather than the more rigorous premarketapproval path to obtain regulatory clearance. The FDA decidedearlier this year to allow Fischer and other companies developingfull-field digital mammography systems to submit 510(k) applicationsrather than PMA filings.

In addition to SenoScan, Fischer's RSNA booth display willinclude Performa, an ultrasound scanner for breast biopsy guidancethat Fischer has licensed from Acoustic Imaging; the MammotestPlus stereotactic breast biopsy system; and CVX, a new angiographicinterventional positioner.