Summary
Aldo Badano is a senior FDA biomedical researcher and director of the Division of Imaging, Diagnostics, and Software Reliability at OSEL/CDRH, with over two decades of service at the agency since 2001. He holds a PhD in Nuclear Sciences from the University of Michigan and has led pioneering regulatory science work, including the VICTRE trial—the first all-in-silico replica clinical study. His portfolio spans evaluation of medical devices, medical AI, and XR, with a focus on data quality, generative AI workflows, and practical pathways for regulatory adoption. Known for building strategic partnerships to accelerate medical AI innovation, he blends deep technical expertise with regulatory pragmatism. An underappreciated strength is his ability to translate complex simulation and imaging science into actionable regulatory studies that influence policy and practice. Based in the United States, he combines research rigor with leadership in shaping how emerging technologies are vetted for safety and effectiveness.
9 years of coding experience
Doctor of Philosophy - PhD, Nuclear Sciences, Doctor of Philosophy - PhD, Nuclear Sciences at University of Michigan