Simpler Grants.gov #RFA-NS-25-021

NIH BRAIN Initiative: Next-Generation Devices for Human CNS Disorders

The National Institutes of Health (NIH) is seeking proposals for the BRAIN Initiative to advance next-generation devices for recording and modulation in the human central nervous system. - Government Buyer: - National Institutes of Health (NIH) - Products/Services Requested: - Development and clinical evaluation of innovative devices for nervous or neuromuscular system disorders - Activities include: - Clinical prototype device implementation - Non-clinical safety and efficacy testing - Design verification and validation - Obtaining Investigational Device Exemption (IDE) for significant risk studies - Conducting small clinical studies to assess device function or final design - OEMs and Vendors: - No specific OEMs or vendors named; solicitation is open to all eligible applicants - Unique/Notable Requirements: - Devices must be novel and require clinical evaluation beyond bench or animal studies - Program is milestone-driven with NIH staff involved in project planning and monitoring - Focus on translational activities to move innovative devices toward clinical use

Description

This funding opportunity encourages investigators to develop therapeutic and diagnostic devices for nervous or neuromuscular system disorders. It supports activities such as clinical prototype implementation, safety and efficacy testing, design verification, obtaining Investigational Device Exemption for significant risk studies, and conducting small clinical studies. The program is milestone-driven and involves NIH staff participation in project planning and progress monitoring. The clinical study aims to provide data on device function or design not obtainable through non-clinical assessments due to device novelty.

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