BRAIN Initiative: Clinical Studies to Advance Next-Generation Devices for Recording and Modulation in the Human Central Nervous System

The National Institutes of Health (NIH) BRAIN Initiative is forecasting a Funding Opportunity Announcement (FOA) to support first‑in‑human or early‑stage clinical studies of next‑generation neural recording and stimulation devices targeting central nervous system (CNS) disorders. The program seeks collaborations between clinical investigators and device manufacturers to generate safety and efficacy data that are otherwise costly and difficult to obtain. Applications may involve non‑significant‑risk (non‑invasive) or significant‑risk (implantable) devices, the latter requiring an FDA Investigational Device Exemption (IDE). Up to three awards are anticipated with total estimated funding of $10 million. The FOA is intended to reduce barriers to public‑private partnerships and accelerate translation of innovative neurotechnologies. • Supports first‑in‑human or early‑stage CNS device studies (recording and/or stimulation). • Open to a wide range of applicants, including universities, nonprofits, tribal governments, and for‑profit entities. • Funding mechanism: Cooperative Agreement (CA) with an estimated $10 M total across three awards. • Anticipated award date: December 1 2027; project start date same day. • No pre‑bid meeting or site visit required; questions deadline not specified. • Contact: BRAIN Initiative Devices, email [email protected].