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Covidien Seeks Participation In FDA-CMS Parallel Review Program

This article was originally published in The Gray Sheet

Executive Summary

The firm’s corporate chief medical officer Michael Tarnoff says Covidien is developing a standard-of-care-disrupting device that would gain from early formal attention by CMS; he hopes to hear from the agencies on acceptance for parallel review by year’s end. Tarnoff said he thinks the program is underutilized.

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