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FDA gives PillCam Colon thumbs down

This article was originally published in The Gray Sheet

Executive Summary

Given Imaging says Feb. 18 it received a "not substantially equivalent" letter from FDA denying its 510(k) application for the PillCam Colon, an ingestible capsule that images the colon. The firm would not disclose details of the letter, but said it is evaluating options to get the device to the U.S. market and is accelerating development of the Colon 2 next-generation capsule. PillCam Colon was approved in Europe in 2006. FDA has cleared PillCam SB 2, for the small bowel, and PillCam ESO 2, for the esophagus. On Feb. 20, Given reported 2007 sales of $112.8 million, a 19% increase over the prior year. The firm's guidance for sales in 2008 is $130 million-$136 million

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