Hologic Sales Drop In Q1 Despite Signs Of Capital-Equipment Market Recovery
This article was originally published in The Gray Sheet
Executive Summary
Women's health firm Hologic reported a 10% decline in its breast health unit quarterly sales compared to last year on Feb. 1, but a 2.5% sequential increase from the prior quarter, indicating that the market for large capital equipment may be stabilizing, the firm said
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Regulatory News In Brief
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.
Regulatory News In Brief
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.
Hologic Expects 2010 Launch Of Tomosynthesis System After FDA Panel Delay
Hologic is now forecasting a late 2010 launch of its Selenia Dimensions tomosynthesis three-dimensional mammography system, after recent discussions with FDA led the firm to back out of a planned June advisory panel review