Hologic's LORAD
This article was originally published in The Gray Sheet
Executive Summary
Full-field digital mammography system gains FDA "approvable" status, with final approval subject to agreement on final labeling, criteria on use of the product and completion of a good manufacturing practices audit. While the first-generation system is based on charge-coupled device (CCD) technology, a second-generation system using amorphous selenium DirectRay direct-to-digital technology is under development, and a PMA supplement filing is anticipated in the first quarter of 2002 (1"The Gray Sheet" Oct. 8, 2001, p. 28)
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