NextTech: Translational Development of Next-Generation Diagnostic and Therapeutic Devices (R18 Clinical Trial Not Allowed)

The National Institutes of Health (NIH), through this Notice of Funding Opportunity (NOFO) RFA-EB-26-004, seeks to accelerate the translation of advanced technologies under the auspices of two key NIH initiatives: the BRAIN Initiative (Brain Research through Advancing Innovative Neurotechnologies) and the HEAL Initiative (Helping to End Addiction Long-term). These programs are at the forefront of federal efforts to address complex brain disorders and the opioid crisis by supporting high-impact innovations in medical technology. The NextTech program is intended to fund the development of next-generation diagnostic and therapeutic devices aimed at preventing, monitoring, diagnosing, and treating disorders within these focal areas. The purpose of this NOFO is to overcome translational barriers encountered after proof-of-concept stages for new devices. These activities should result in device readiness for First-in-Human (FIH) clinical studies. Applicants are encouraged to undertake projects that include engineering improvements, usability enhancements, and activities necessary for regulatory approvals for human use. While clinical trials are not permitted under this mechanism, the work should move technologies to a stage where human trials can begin immediately following the award’s conclusion. The funding supports a range of technical development activities. These may include, but are not limited to, bench validation, biocompatibility testing, design refinement, and manufacturing scale-up. As the NOFO falls under the R18 mechanism, it focuses on the practical application and deployment of devices rather than basic or exploratory research. The NIH expects that funded projects will demonstrate clear translational milestones and show how the proposed work will enable the device to meet FDA or equivalent human-use requirements. Eligibility for this opportunity is highly inclusive. Public and private higher education institutions, nonprofits (with or without 501(c)(3) status), state and local governments, tribal organizations, and for-profit entities, including both small businesses and other commercial organizations, are eligible to apply. The notice also extends eligibility to faith-based organizations, foreign entities, and agencies of the federal government, reflecting NIH's emphasis on cross-sector collaboration for translational technology development. There is no cost-sharing or matching requirement. The anticipated timeline indicates the forecasted release of the full funding opportunity on July 17, 2026, with an estimated application deadline of September 18, 2026. Awards are expected to be issued by June 18, 2027, and projects are slated to begin by July 18, 2027. The program anticipates awarding approximately four grants, with an estimated total program funding of $6,000,000. Specific award ceilings and floors were not provided in the forecast. Submission will follow standard NIH application protocols through Grants.gov once the opportunity is posted. While detailed application components were not listed in this forecast notice, applicants can expect to adhere to NIH’s standard format for research grant applications. The primary point of contact for programmatic questions is the NIBIB Program Officer team, which can be reached via the dedicated email [email protected].