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FDA Radiology Panel Will Consider Computer-Aided Detection Issues In March

This article was originally published in The Gray Sheet

Executive Summary

The question of how best to evaluate computer-aided detection tools for medical imaging procedures will be put to FDA advisors at a two-day meeting next month

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FDA Panel Backs Testing Of Concurrent And Sequential Mammography CAD

FDA should require sponsors of computer-aided detection for mammography to test their devices with both sequential and concurrent reading approaches, FDA's Radiological Devices Advisory Panel recommends

FDA Panel Backs Testing Of Concurrent And Sequential Mammography CAD

FDA should require sponsors of computer-aided detection for mammography to test their devices with both sequential and concurrent reading approaches, FDA's Radiological Devices Advisory Panel recommends

CAD and mammograms

Using computer-aided detection to help interpret mammograms in a single-read results in significantly more sensitive diagnoses (90.4%) than single-reads without CAD (81.4%), and slightly better sensitivity than double-reads without CAD (88.0%), according to a review of 231,221 screening mammograms by Matthew Gromet of Charlotte Radiology. "With manpower and cost constraints limiting the use of double-reading in the United States, CAD appears to be an effective alternative," Gromet writes in a study published online the week of Feb. 10 in the American Journal of Roentgenology. The study used Hologic's R2 ImageChecker. CAD tools for medical imaging will be the subjects of an FDA advisory panel meeting March 4-5 ("1The Gray Sheet" Feb. 11, 2008, p. 7)

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