Hologic To Delay Digital Mammography Launch Pending Selenia Approval
This article was originally published in The Gray Sheet
Hologic's Selenia digital mammography system for breast cancer screening and detection should receive FDA market go-ahead by year-end, the firm claims. A PMA supplement for the second-generation digital mammography system, which incorporates proprietary amorphous selenium DirectRay technology, will be filed shortly
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PMA supplement approval of the second-generation full-field digital mammography system for screening and diagnosis of breast cancer is announced Oct. 2. Shipments of the system, which uses Hologic's DirectRay amorphous-selenium, direct-to-digital image receptor technology, will begin by year-end. The technology also will be available as a field upgrade for the 3,000 Lorad M-IV screen-film systems. Hologic's first-generation Lorad FFDM system, using charge-coupled device (CCD) technology, was approved by FDA in March (1"The Gray Sheet" March 25, 2002, p. 13)...
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