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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Hologic panel: FDA's Radiological Devices Panel will weigh in on Hologic's Selenia Dimensions 3-D digital mammography tomosynthesis system on Sept. 24 in Gaithersburg, Md. The firm is seeking PMA approval for both screening and diagnostic indications. The panel is a long time in coming: the firm backed out of a June 2009 panel review to strengthen its case for the product, which it had originally hoped to launch in 2008. The firm most recently forecast approval late this year (1"The Gray Sheet" Feb. 8, 2010). The tomosynthesis technology is designed to address what Hologic calls the primary limitation of 2-D digital mammography, "namely, the superposition of normal breast anatomy that may mask a breast cancer.
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