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QUOTED. 5 May 2020. Miles Rosen.

Executive Summary

Pelvalon CEO Miles Rosen spoke to Medtech Insight about the company’s journey from US FDA de novo authorization to Medicare HCPCS payment code for its Eclipse System, a nonsurgical device used for bowel control in women.

“Start thinking about the reimbursement process early. The time to think about it is really not when you’re getting to market, but before. Even as you’re submitting to FDA, keep in mind that the stuff you’re submitting to FDA will also be something that can be used later on for reimbursement.” – Miles Rosen, CEO, Pelvalon

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