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CTI working to overturn FDA decision

This article was originally published in The Gray Sheet

Executive Summary

Computerized Thermal Imaging reports May 22 it has "provided additional analysis and...had productive discussions with the FDA staff" on the agency's "non-approvable" letter for BCS 2100 thermal breast imaging system. Rejection of the PMA followed a December panel meeting in which members faulted the Portland, Ore. firm's 173-patient "post-hoc" retrospective study as inadequately powered (1"The Gray Sheet" Dec. 16, 2002, p. 11)...
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