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CTI BCS-2100 Breast Imaging System PMA Panel Review Set For Oct. 16

This article was originally published in The Gray Sheet

Executive Summary

Computerized Thermal Imaging has lined up 27 U.S. and six international distributors for the launch of its BCS 2100 thermal breast imaging system following FDA approval

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CTI Breast Imaging System Panel Review Falters On Retrospective Analysis

Computerized Thermal Imaging, Inc.'s "post-hoc," retrospective analysis of breast masses viewed with the BCS 2100 thermal breast imaging system failed to convince FDA's Radiological Devices Advisory Panel of the device's effectiveness

CTI Breast Imaging System Panel Review Falters On Retrospective Analysis

Computerized Thermal Imaging, Inc.'s "post-hoc," retrospective analysis of breast masses viewed with the BCS 2100 thermal breast imaging system failed to convince FDA's Radiological Devices Advisory Panel of the device's effectiveness

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Kennedy spotlights West Nile virus: Pathogen inactivation technology deemed "promising" in written remarks from Sen. Edward Kennedy (D-Mass.) to FDA commissioner-nominee Mark McClellan, MD/PhD. "Should it be a priority for FDA to evaluate this exciting new technology?" Kennedy asks. "Pathogen inactivation may prove valuable as an approach to reducing risk in blood products," McClellan replies. "These approaches, however, must be carefully evaluated for their immediate and long-term safety," he cautions...

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