ARPA-H Launches Hunt for First FDA-Authorized Agentic AI to Treat Heart Disease

The Advanced Research Projects Agency for Health is betting that artificial intelligence can fill a gap no hiring surge ever will: the absence of cardiologists in nearly half of American counties.

ARPA-H's new ADVOCATE program — Agentic AI-Enabled Cardiovascular Care Transformation — is soliciting proposals for what would become the first FDA-authorized agentic AI system capable of providing round-the-clock specialty care for heart failure and post-heart attack patients. Full proposals are due April 1, 2026.

A Cardiologist Shortage That AI Could Address

According to research published in the Journal of the American College of Cardiology, 46 percent of U.S. counties lack a single cardiologist. Just 2.5 percent of American patients currently receive the lifesaving heart disease medications recommended by clinical guidelines. Cardiovascular disease remains the nation's deadliest chronic condition.

ARPA-H program manager Haider Warraich, MD, has framed ADVOCATE as an attempt to close that access gap permanently — not by replacing physicians, but by extending their reach through autonomous AI agents that never clock out.

Three Technical Tracks, One FDA Pathway

The program funds three distinct technical areas. The first covers patient-facing AI agents that can access medical records, provide dietary and exercise guidance, schedule appointments, deliver diagnoses, and even write or modify prescriptions. The second builds a supervisory agent layer to monitor clinical AI for safety and effectiveness. The third recruits health systems willing to integrate the technology into real clinical workflows.

All three tracks converge on an aggressive 39-month timeline that includes FDA authorization — a pace more typical of DARPA than traditional medical device approvals. ARPA-H is working directly with the FDA to establish regulatory pathways for high-risk AI medical devices.

The program advances the White House AI action plan released in July 2025 and sits under ARPA-H Director Alicia Jackson, a former DARPA leader.

What Grant Seekers Should Know

ADVOCATE uses Other Transaction Agreements rather than standard grants, meaning reduced compliance overhead and milestone-based payments. Teams must assemble cross-disciplinary groups spanning AI development, clinical medicine, and health system operations.

Solution summaries closed February 27, but full proposals remain open until April 1 via sam.gov. Selected teams will be announced by June 2026. For deeper analysis of how ARPA-H funding works and what makes competitive proposals, the Granted blog covers federal health research opportunities in detail.