FDA knock-back for thermal breast imager:
This article was originally published in Clinica
Executive Summary
The US FDA has rejected Computerised Thermal Imaging's (CTI) application to market its breast imaging system, which measures heat patterns to help determine if a lump is cancerous. The FDA, whose decision was in accord with the 4-3 vote against approval made last year by its advisory panel (see Clinica No 1037, p 13), has expressed concerns regarding Portland, Oregan-based CTI's clinical trial and analysis of its trial data.