Qian Cao

I am a regulatory scientist in the Division of Imaging, Diagnostics, and Software Reliability in the Center for Devices and Radiological Health at FDA. Part of my work is to review novel premarket medical device submissions to ensure that safety and efficacy claims are backed by sound, scientific evidence. In addition, I lead several research projects to support the development and evaluation of AI-enabled SaMDs.

My current research focus include:

• Uncertainty Quantification for AI-enabled Systems
• Multimodal Learning with Quantitative Biomarkers
• Survival Analysis

I hold a Ph.D. in biomedical engineering from Johns Hopkins University, where I worked on modeling imaging chains, image analysis, and reconstruction algorithms for musculoskeletal CT imaging. Before this, I obtained my B.S. in biomedical engineering and B.S.A.S in systems science & engineering from Washington University in St. Louis, where I received great mentorship that introduced me to medical imaging research.