Fischer Taking Chance With SenoScan 510(k), Leaving PMA Route Open
This article was originally published in The Gray Sheet
Executive Summary
Fischer Imaging's premarket notification submission for the SenoScan full-field digital mammography system is readily convertible into a PMA, should FDA reject the 510(k) approach for the device, as the agency has done in the past.
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RSNA In Brief
GE/Amersham Health: Firms' research agreement inked Nov. 27 will focus initially on radiopharmaceuticals to be used with positron emission tomography (PET) in diagnosis of Parkinson's disease. FDG and FDOPA are among pharmaceuticals under study. GE Medical Systems also announces FDA approval for its sixteen-slice PET system, to be launched in the U.S. next year...
RSNA In Brief
GE/Amersham Health: Firms' research agreement inked Nov. 27 will focus initially on radiopharmaceuticals to be used with positron emission tomography (PET) in diagnosis of Parkinson's disease. FDG and FDOPA are among pharmaceuticals under study. GE Medical Systems also announces FDA approval for its sixteen-slice PET system, to be launched in the U.S. next year...
Siemens/Fuji
Long-term supply agreement allows Siemens to offer Fuji's computed radiography (CR) systems with its full-field digital mammography (FFDM) technology. "Our strategic decision for a CR-based FFDM solution was driven by our determination that flat detector technology still has to mature for mammography applications," Frank Anton, MD president, special systems division, Siemens Medical Engineering Group stated in a Nov. 28 release. Fuji CR will be offered internationally with FFDM, which is installed as an upgrade to Siemens' Mammomat 3000 and 3000 Nova instruments. GE Medical Systems' Senographe 2000, based on flat detector technology, is the only digital mammography system currently available in the U.S. (1see related story, p. 5)