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Digital mammography postmarket studies need almost 12,000 patients -- FDA guidance.

This article was originally published in The Gray Sheet

Executive Summary

DIGITAL MAMMOGRAPHY POSTMARKET STUDIES OF ALMOST 12,000 WOMEN should be performed to "assess the effectiveness of digital relative to analog screening," according to an FDA guidance document released Sept. 8. The parameters and conditions outlined by FDA for testing the sensitivity of digital mammography indicates that at least "11,894 women must be selected for the screening study," FDA says. The agency released the guidance at a Sept. 11 meeting of the Radiology Devices Panel in Rockville, Maryland, but it was not discussed during the meeting.
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