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J&J/Ethicon Endo-Surgery's Sedasys

This article was originally published in The Gray Sheet

Executive Summary

Computer-assisted personalized sedation system gains CE-mark approval in Europe for use with routine colonoscopy and screening of the upper gastrointestinal tract, and Canadian approval for use with routine colonoscopy, the firm announces May 3. "We look forward to the launch of the system in these markets, as early as the end of this year," said Karen Licitra, company group chair and worldwide franchise chair, Ethicon Endo-Surgery. In the U.S., Johnson & Johnson's Ethicon Endo-Surgery unit is appealing a recent FDA "not approvable" letter for the device (1"The Gray Sheet" April 26, 2010)
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