Caption Health, Brisbane (United States of America)
Sam Surette is the Head of Regulatory Affairs and Quality Assurance at Caption Health. Sam obtained acceptance of the company's AI-guided imaging system into the U.S. Food & Drug Administration's (FDA) Breakthrough Devices Program, helped design the multi-center pivotal study to validate its clinical effectiveness, and lead the company to landmark De Novo FDA authorization. Prior to joining Caption Health, Sam spent four years as a reviewer at the FDA in the Division of Cardiovascular Devices, where he reviewed IDEs, 510(k)s, PMAs, and other submissions for cardiac electrophysiology devices, including the first FDA approval of a professional-use automated external defibrillator. He has a bachelor's degree in biomedical engineering from Washington University in St. Louis.