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Hologic Lorad Selenia

This article was originally published in The Gray Sheet

Executive Summary

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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