This article was originally published in The Gray Sheet
Optical biopsy system for assisting endoscopists in identifying potentially malignant polyps in the colon is deemed approvable by FDA's Gastroenterology and Urology Devices Panel at a Nov. 19 meeting in Rockville, Maryland. The panel voted 4-3 to recommend FDA approval contingent upon performance of post-approval studies to measure the device's effectiveness in flexible sigmoidoscopy, the field in which the panel determined the device would be most applicable. Phase II trial results presented to the panel were limited to data from colonoscopy procedures
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