Description
This NIH RFA seeks innovative investigators to advance next‑generation diagnostic and therapeutic device technologies toward readiness for first‑in‑human (FIH) trials. The program supports technology development, optimization, and regulatory‑preparatory studies aligned with the BRAIN and HEAL initiatives. Up to four awards will be made, with total anticipated funding of $6 million. Applicants may be for‑profit, nonprofit, governmental, tribal, or foreign entities that meet eligibility criteria. The award mechanism is an R18 research‑demonstration grant; clinical trials are not allowed under this award. Successful proposals will move promising prototypes through engineering, pre‑clinical validation, and preparation for regulatory submission.
• Target area: biomedical imaging, neurotechnology, addiction, aging, vision, oral health, and related health challenges.
• Funding: $6 M total (≈ $1.5 M per award).
• Award type: R18 (Research Demonstration and Dissemination).
• No‑clinical‑trial clause: devices must not be used in human trials under this award.
• Eligible entities: wide range (state, local, tribal, for‑profit, nonprofit, foreign institutions).
• Expected deliverables: prototype refinement, pre‑clinical data, regulatory pathway plans, data‑sharing compliance.