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The Full Picture: Why FDA Approval Depends on More Than Your Clinical Trial
Speaker: Tony Fields
Thursday, September 12 (In-person)
Meeting endpoints in a successful clinical trial ensures that the FDA will approve a medical device, right? As it turns out, there’s more to the picture. Tony Fields was VP of R&D at Emphasys and COO at Claret Medical, and in his career he saw FDA deny approval for an Emphasys device that met all primary and secondary endpoints in a trial–but, conversely, approve a Claret device that failed to meet its endpoints. How can this be? What other factors might matter to FDA? Join us Thursday, September 12 to find out.