Use of Artificial Intelligence for Cardiovascular Endpoints (Oct 15, 2025)

WELCOME & OPENING REMARKS

Current Regulatory Status for the acceptance of AI-generated cardiovascular endpoints

• Comments on the Draft Guidance for use of AI – Sanjeev Bhavnani- Former Senior Medical Officer, FDA Digital Health Center of Excellence, Digital Health and AI Regulatory Science Scripps Clinic
• How to get an AI-generated endpoint approved for use in clinical trials – Jeff Siegel, Office Director – Office of Drug Evaluation Sciences at FDA
• Regulatory concerns of AI-generated cardiovascular endpoints – Jordan Pomeroy, Lead Physician, Division of Cardiology and Nephrology

Discussion: What is necessary for regulatory acceptance of CV endpoints generated with AI tools?

PRESENTATIONS, DEBATE, AND DISCUSSION:

Demonstration of AI tools in order to drive discussion on attributes necessary for regulatory acceptance and applicability to a variety of cardiovascular endpoints.

• Endpoint adjudication AI Platforms: what parts of the process are amenable to AI, how often do we need humans in the loop, what if AI approaches disagree, how to deal with different source documents, what constitutes a minimal data package, are different AI approaches needed for different endpoints?
• Cardiovascular diagnostic data AI Platforms – can AI-derived endpoints from EKG, echocardiographic, and CTA data be used to support regulatory outcomes? Which outcomes? Do algorithms need to be regulatory agencies? Is an approved algorithm sufficient to support endpoint determination in a clinical trial? What role is there for “human in the loop”? How are updates to the algorithm viewed?
• AI-based detection of ADRs and medication compliance –  are agentic AI reasonable approaches to replacing human interaction? Are different models needed for different types of adverse events or study populations? What are the training data requirements?

CLOSING REMARKS AND NEXT STEPS

AI-generated cardiovascular endpoints – what have we learned today, what future work is needed for more widespread regulatory acceptance? Jordan Pomeroy, Lead Physician, Division of Cardiology and Nephrology