Topic Tag: Session I

Lecture “Conflict of Interest & Product Development” by Anthony DeMaria, MD

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Learning Objectives

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Conflict of Interest and Product Development

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Lecture “Guideline Requirements for Diagnostic Devices” by Roxana Mehran, MD

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Lecture “Reimbursement for Diagnostic Devices” by Lori Ashby, CMS

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Lecture “Regulatory Review of Cardiovascular Diagnostic Devices – FDA Perspective” by Marco Cannella, PhD, FDA

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Lecture “Introduction to the Cardiac Cath Lab” by Morton Kern, MD

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Preclinical, Early Feasibility, and Safety Study for Device Development

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Clinical Endpoints & Biostatistics

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Requirements for CV Devices Approval

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