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Hologic’s Digital Mammography Prospects Lift Stock 76% In October

This article was originally published in The Gray Sheet

Executive Summary

Anticipation of imminent FDA approval of Hologic's Lorad full-field digital mammography system resulted in a 76.2% jump in the firm's stock price for October

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Hologic's LORAD

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)

Recent eMDR Change By FDA Asks Adverse Event Reporters About Third-Party Servicers

The addition of the question “Was this device serviced by a third party servicer?” to adverse event reports filed through the US FDA’s electronic Medical Device Reporting system could prove helpful for the agency and device makers, experts tell Medtech Insight. Industry has long complained about poor work performed by servicers – and loudly groused that they’re not regulated.

Experts: HHS Review Proposal May Free Industry From Regulatory Red Tape

Attorneys tell Medtech Insight a recent proposal to review regulations every 10 years could lift some burdens from the medical device industry, but warned that the full effects may not be seen for some time.




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