07/08/25 - Innovation Grand Rounds

Speaker/s: 

Dr. Hanmin Lee, MD ( PI, UCSF Stanford Pediatric Device Consortium) will be leading a panel discussion with UCSF clinicians Dr. Benjamin Padilla, MD (Currently with Phoenix Children's), and Dr. Sunghoon Kim, MD and the Atricure team leads (Jonathan McElwee, Director, Regulatory Affairs and Paul Ahlemeyer, Senior Director Product Marketing) in collaborating on this pioneering PDC  project in pediatrics.

Dr. Alberto Jarrin Lopez, MD (Research Fellow, UCSF Surgical Innovations and PDC) will be moderating a Q&A session after the panel discussion. 

Title: 
Label Expansion for Pediatric Medical Devices: Insights from the AtriCure x UCSF-Stanford PDC Real-World Evidence Initiative

Summary: 
Real-world evidence (RWE) is increasingly recognized as a valuable regulatory tool for evaluating medical devices—particularly in pediatrics, where small sample sizes, ethical considerations, and limited commercial incentives hinder traditional clinical trials. Here, we present a successful case of label expansion for the AtriCure CryoAblation probe in children over 12 years of age. Through this panel discussion, we aim to illustrate how academic–industry collaboration can support medical device start-ups in pursuing FDA 510(k) clearance for expanded labeling.