ARPA-H, the U.S. government’s health “moonshot” agency, plans to commit $62.7 million to develop partially autonomous AI that would help treat heart failure — and, crucially, be authorized by the FDA.
The program, called ADVOCATE, aims to produce the first FDA-authorized “agentic” AI that can provide 24/7 specialty care for heart failure. The vision: AI agents trusted to assess symptom severity, order lab tests, adjust medications, and modify appointments, diet and exercise — autonomously, within guardrails.
The problem it targets
Roughly 6.7 million Americans live with heart failure, and many don’t get optimal treatment because specialist access is limited. ARPA-H’s bet is that clinical AI agents could close that gap for the deadliest chronic disease in the U.S.
Who’s building it
The first year commits $33.7 million, with the rest subject to renegotiation. Initial awards went to health-tech firms Atman Health, UpDoc and Tempus AI, plus teams from Stanford, Duke and Kaiser Permanente. The ambition is striking — autonomous AI that prescribes is a significant regulatory and safety leap — and the FDA-authorization requirement is the guardrail that will determine whether it can responsibly reach patients. Not medical advice.