Executive Summary
NIH's BRAIN and HEAL Initiatives fund design-directed development of implantable, minimally invasive and non-invasive neurotech devices toward first-in-human readiness. About $6M in FY2028 for 8 to 12 R18 awards, up to 3 years. Small businesses can apply. Opens January 1, 2027; first due date February 1, 2027, 5:00 PM local.
The deciding factor is a path to human use. NextTech funds engineering that starts from preliminary proof-of-concept data and ends with a device ready for first-in-human testing. Hypothesis-driven research, animal models, biomarkers, drugs and clinical efficacy studies are not reviewed.
Solicitation at a Glance
- Agency: National Institutes of Health (NIH) BRAIN and HEAL Initiatives, led by NIBIB with NEI, NIA, NIAAA, NICHD, NIDCR, NIDA, NIMH and NINDS
- Opportunity: NextTech: Translational Development of Next-Generation Diagnostic and Therapeutic Devices (R18 Clinical Trial Not Allowed)
- Number: RFA-EB-28-004
- Award Vehicle: R18 grant
- Funding: About $6M in fiscal year 2028 for about 8 to 12 awards; budgets should rarely exceed $750,000 in direct costs a year
- Project Period: Up to 3 years
- Due Dates: Opens January 1, 2027. Due February 1, 2027, then September 17, 2027, May 26, 2028, February 1, 2029, September 19, 2029 and February 1, 2030, 5:00 PM local time (expires February 2, 2030)
Think your company qualifies? Talk with BW&CO before the February 1, 2027 deadline.
What Is NextTech?
NextTech is a BRAIN and HEAL Initiative funding announcement, posted October 23, 2026, for design-directed development of next-generation devices that diagnose, treat or rehabilitate conditions of the nervous system. It covers non-invasive, minimally invasive and implantable devices.
What Problem Is NIH Trying to Solve?
Promising neurotechnology often stalls between a lab prototype and a device that can be tested in people. NIH wants to fund the engineering that closes that gap, so devices reach readiness for first-in-human studies.
Priority Capability Areas: What NIH Is Looking For
- Design-directed development: engineering work toward defined device specifications, not hypothesis-driven research
- Device types: non-invasive, minimally invasive and implantable devices
- Uses: diagnosis, treatment and rehabilitation
- Path to human use: a plan that ends with readiness for first-in-human testing
- Translational experience: regulatory, manufacturing and commercialization know-how on the team
Funding and Award Terms
- Total: about $6M in fiscal year 2028 for about 8 to 12 awards; future amounts depend on appropriations
- Budget: not limited, but should rarely exceed $750,000 in direct costs a year
- Period: up to 3 years
- Cost sharing: not required
Eligibility
- Companies: small businesses and other for-profit organizations are eligible
- Foreign organizations: eligible; foreign components are allowed
- Foreign subawards: applications with foreign subawards or subcontracts are noncompliant
- Starting point: projects build on preliminary proof-of-concept studies
- Drugs and biologics: any drug or biologic used with the device must already be FDA approved
How to Apply
- Wait for the open date: submissions open January 1, 2027
- Check registrations: make sure your SAM.gov, Grants.gov and eRA Commons registrations are active
- Write a design-directed plan: set device specifications and engineering milestones
- Show the path to human use: cover regulatory, manufacturing and commercialization steps
- Submit: by 5:00 PM local time on February 1, 2027 or a later due date
What Happens After You Submit?
- Review: applications go through NIH peer review and advisory council review
- Key question: reviewers consider whether the team has the translational experience to move toward human use within five years
- Award: NIH funds selected R18 projects for up to 3 years
Is This Opportunity a Good Fit for Your Company?
It fits neurotech device companies with bench or proof-of-concept data and a credible regulatory and manufacturing plan, including neural interfaces, neuromodulation and neural sensing hardware. It is a weak fit for teams doing basic research, animal-model studies, biomarker work, or drug and biologic development.
How BW&CO Can Help
BW&CO has helped deep-tech and dual-use founders secure more than $350M in non-dilutive funding. For NIH device development awards like NextTech, we help you:
- Check fit: confirm your project is design-directed and in scope
- Frame the path to human use: set out regulatory and manufacturing steps reviewers expect
- Build the research strategy: turn your engineering plan into clear milestones
- Plan the budget: stay near the $750,000 direct-cost guidance
- Pick the right due date: choose a cycle that fits your data and team
Plan Your NextTech Application
Frequently Asked Questions
Who issued RFA-EB-28-004?
The NIH BRAIN and HEAL Initiatives, led by NIBIB with eight other NIH institutes.
When can I apply?
Submissions open January 1, 2027. The first due date is February 1, 2027, 5:00 PM local time, with later cycles through February 1, 2030.
How much funding is available?
NIH plans to commit about $6M in fiscal year 2028 for about 8 to 12 awards.
How large can a budget be?
Budgets are not limited but should rarely exceed $750,000 in direct costs a year, for up to 3 years.
Can a small business apply?
Yes. Small businesses and other for-profit organizations are eligible.
What will not be reviewed?
Projects without a path to human use, and projects focused on animal models, diagnostic procedures, biomarkers, rehabilitation strategies, small molecules, biologics, or clinical safety and efficacy.
Can foreign teams take part?
Foreign organizations can apply and foreign components are allowed, but foreign subawards are not.
Is cost sharing required?
No.
Can BW&CO help with a NextTech application?
Yes. BW&CO can help you check fit, frame the path to human use and build the application. Book a call with our team.
Source: NIH Guide: RFA-EB-28-004, NextTech Translational Development of Next-Generation Devices