AI-Enabled Systems in Medical Imaging: USFDA Research and Regulatory Pathways

Kyle J. Myers, Ph.D., received bachelor?s degrees in Mathematics and Physics from Occidental College in 1980 and a Ph.D. in Optical Sciences from the University of Arizona in 1985. Since 1987 she has worked for the Center for Devices and Radiological Health of the FDA, where she is the Director of the Division of Imaging, Diagnostics, and Software Reliability in the Center for Devices and Radiological Health?s Office of Science and Engineering Laboratories. In this role she leads research programs in medical imaging systems and software tools including 3D breast imaging systems and CT devices, digital pathology systems, medical display devices, computer-aided diagnostics, biomarkers (measures of disease state, risk, prognosis, etc. from images as well as other assays and array technologies), and assessment strategies for imaging and other high-dimensional data sets from medical devices. She is the FDA Principal Investigator for the Computational Modeling and Simulation Project of the Medical Device Innovation Consortium. Along with Harrison H. Barrett, she is the coauthor of Foundations of Image Science, published by John Wiley and Sons in 2004 and winner of the First Biennial J.W. Goodman Book Writing Award from OSA and SPIE. She is an associate editor for the Journal of Medical Imaging as well as Medical Physics. Dr. Myers is a Fellow of AIMBE, OSA, SPIE, and a member of the National Academy of Engineering. She serves on SPIE?s Board of Directors (2018-2020).