Luke Ralston

Luke Ralston has been a Biomedical Engineer and Scientific Reviewer for over 18 years with FDA’s Office of Cardiovascular Devices within CDRH. He has been the lead reviewer or project lead on over 600 submissions with an emphasis on Automated External Defibrillation, Artificial Intelligence/Machine Learning (AI/ML), Software, and battery technology. He has served as the primary consultant on combination product reviews with other Centers within FDA as well as the FDA representative to other government agencies, industry groups, consumer groups, research institutions, and international standards organizations. He currently serves as the digital health focal point for cardiovascular devices within FDA, is a member of the FDA AI/ML working group, and is the FDA liaison to the Association for the Advancement of Medical Instrumentation (AAMI) for Cardiac Rhythm Management Devices (CRMD).