February 27, 2020

ACR Leaders Participate in FDA Workshop on AI in Radiological Imaging

Leaders and staff representatives of the American College of Radiology® (ACR®) and ACR Data Science Institute® (DSI) participated Feb. 25–26 in the Food and Drug Administration’s (FDA) public workshop, “Evolving Role of Artificial Intelligence in Radiological Imaging.”

The workshop featured presentations and panel discussions by Bibb Allen Jr., MD, FACR (ACR DSI chief medical officer), Keith J. Dreyer, DO, PhD, FACR (chair of the ACR Commission on Informatics and ACR DSI chief science officer), and Laura Coombs, PhD (ACR senior director of informatics).

The first day of the workshop focused on trends, best practices and regulatory and validation considerations for AI devices intended to automate components of diagnostic radiology workflow. AI-guided image acquisition tools for ultrasound were highlighted on the second day.

ACR representatives presented on such topics as emerging trends in radiological AI software, the monitoring of AI algorithms pre- and post-FDA clearance, and the evaluation of AI software for radiological applications. They discussed the DSI’s various initiatives and stressed the importance of ensuring clinical usefulness, care quality and patient safety during AI assessment and performance monitoring.

Moving forward, the FDA will use the workshop proceedings to help inform the agency’s regulatory policies and approaches to autonomous AI and AI-guided image acquisition systems.