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Ep. 535 Genicular Artery Embolization: Current Controversies and Insights with Dr. Sid Padia and Dr. Osman Ahmed

BackTable Vascular & Interventional

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Navigating FDA Approval and Clinical Trial Benchmarks for New Medical Devices

This chapter examines the shifting benchmarks for preclinical and clinical data needed for new devices, focusing on Genicular Artery Embolization (GAE). It highlights the complexities of FDA requirements for safety and effectiveness data, as well as the challenges in designing clinical trials that satisfy regulatory standards while prioritizing patient safety.

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