Covidien Seeks Participation In FDA-CMS Parallel Review Program

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.

Medtronic Minimally Invasive Therapies is in talks with FDA and CMS about participating in the agencies’ parallel review pilot program for an investigational device the firm believes is about two to three years from market launch, according to a company official.

Michael Tarnoff, the firm’s corporate chief medical officer, would not identify the pipeline product in question, but the firm believes it would benefit from the program because “we are

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