Gastroenterology and Artificial Intelligence: 2nd Annual Artificial Intelligence Summit | October 2020-Streamlining Regulatory Approvals

Video Transcription

Video Summary

In this video, John Vargo and Klaus Mergener, the current and immediate past presidents of the ASGE, discuss the integration of AI and gastrointestinal (GI) practices. They introduce Mark Antonino, the team lead for gastroenterology and endoscopy devices at the FDA, who discusses the regulatory approval process for computer-aided endoscopic AI devices. Mark explains the classification of medical devices based on risk and discusses the de novo pathway for AI devices. He also highlights the importance of prospective clinical studies, study endpoints, statistical analysis plans, and standalone testing in obtaining FDA approval. Mark recommends utilizing the FDA's pre-submission program for obtaining feedback before submitting a marketing application.

Asset Subtitle

Mark Antonino, MS

Keywords

AI integration in GI practices

Gastrointestinal practices and AI

Regulatory approval process for AI devices

Medical device classification and risk

FDA's pre-submission program