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FDA Votes Against CTI Breast Imaging System

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PORTLAND, Ore., Dec. 13 -- Computerized Thermal Imaging (CTI) announced this week that the FDA's Radiological Devices Panel met yesterday and recommended by a vote of 4-to-3 that the FDA deny approval of CTI's infrared breast imaging system. Panel members said they believe the technology is promising but that they need more information before it can recommend approval. A formal decision will follow from the FDA, CTI said. "With the solid clinical results and seven years of research and development on our breast imaging system, we are deeply disappointed by the Panel's recommendation," said...Read full article

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    Published: December 2002
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