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FDA panel votes down CTI product

Article

An advisory committee to the FDA recommended Dec. 10 against the approval of an optical imaging technology being developed by Computerized Thermal Imaging (Portland, OR). The FDA's Radiological Devices Panel voted 4 to 3 that the FDA deny approval of the

An advisory committee to the FDA recommended Dec. 10 against the approval of an optical imaging technology being developed by Computerized Thermal Imaging (Portland, OR). The FDA's Radiological Devices Panel voted 4 to 3 that the FDA deny approval of the company's infrared breast imaging system. Panel members described the technology as promising but decided more clinical data were necessary for members to recommend approval. The FDA has yet to decide on the matter.

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