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Translational Neural Devices (R61/R33 - Clinical Trial Optional)

National Institutes of Health · Opportunity PAR-25-053

Deadline January 28, 2027 141 days left
Award range Not stated
Total program funding
PostedOctober 29, 2024

Who can apply

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

About this opportunity

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage investigators to pursue translational activities and small clinical studies to advance the development of therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent small clinical study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This NOFO is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress.

Award history — this exact opportunity

NIH RePORTER lists 3 funded awards under PAR-25-053 across 3 organizations.

Awards by fiscal year 2026: 3
Award size (min / median / max) $493k / $572k / $723k

Total award obligations, not per-year amounts.

Recent awardees include: CLEVELAND VA MEDICAL RESEARCH/ED/FDN, WASHINGTON UNIVERSITY, UNIVERSITY OF COLORADO DENVER.

Source: NIH RePORTER, matched on the exact opportunity number. NIH publishes success rates by institute and activity code — source.

Portfolio context — this listing covers more than this opportunity

This opportunity is funded under Assistance Listing 93.853 (“Extramural Research Programs in the Neurosciences and Neurological Disorders”), a broad federal program that made about 1102 new awards per year over the last five fiscal years (median award $457k). Those figures describe that whole portfolio — not this specific solicitation, so we don't show them as if they were this opportunity's track record.

Applicant counts per solicitation are not published by any federal agency — no one can honestly sell you that number. NIH publishes success rates by institute and activity code — source.

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