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CTI (Computerized Thermal Imaging) hits back at FDA over breast imaging PMA (Pre-market Approval) decision

This article was originally published in Clinica

Executive Summary

Computerized Thermal Imaging (CTI) is trying unusually aggressive tactics after failing to win FDA approval for its thermal breast imaging device. The company filed a citizen petition with the agency late last month, demanding that the agency correct the administrative record on its premarket approval application, claiming that "pervasive bias" by the review staff "severely and improperly prejudiced" the submission.

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