ARPA-H selected UpDoc, Tempus AI, and Atman Health for ADVOCATE, a federal program aimed at building FDA-authorized agentic AI tools to manage heart disease. The initiative reflects the agency’s push to move from prototype AI to regulated, deployable clinical systems. The partners bring different strengths across health data operations and model development, with a shared focus on producing tools that can be authorized for patient care workflows rather than remaining limited to research settings. For biotech and med-tech, the program is a concrete signal that AI toolchains—especially those framed as agentic systems—are moving into the FDA’s authorization pipeline, affecting how companies structure evidence generation and documentation. The selection also increases competition for AI-enabled cardiovascular care solutions, while creating new requirements around validation, safety monitoring, and ongoing performance assessment.