NIH

Forecasted

FOR-NS-25-017

Small Business Translator: MedTech and Digital Health Technologies

Summary

AI-generated

Small Business Technology Development for Prevention, Monitoring, Diagnosis, and Treatment

This NIH NOFO supports small business concerns (SBCs) in translating device technologies toward clinical application. The program targets prevention, monitoring, diagnosis, and treatment of disorders across NIH missions, with emphasis on neuroscience (Blueprint for Neuroscience Research, BRAIN Initiative) and opioid addiction (Helping to End Addiction Long-term, HEAL Initiative). Eligible technologies span diagnostic, therapeutic, rehabilitative, and monitoring devices—including wearables, digital health tools, imaging-based biomarkers, in vitro diagnostics, implantable or non-invasive systems, and medical-device-development-tools (MDDT). Supported activities include clinical prototype implementation, non-clinical safety and efficacy testing, design verification and validation, obtaining Investigational Device Exemption (IDE) approval for Significant Risk studies, or Institutional Review Board (IRB) approval for Non-Significant Risk studies. Clinical studies addressing safety, usability, feasibility, and efficacy are in scope.

The program is milestone-driven and structured as a cooperative agreement, meaning NIH program staff negotiate final project plans and monitor progress. Funding covers laboratory-based activities; applicants may also request support for consultants in regulatory affairs, reimbursement, intellectual property, commercialization, and strategic partnerships, as well as contract services for animal testing, sterilization, biocompatibility, manufacturing, and clinical support.

Who can apply: Small business concerns (SBCs); those with established device collaborations or developing proprietary devices are eligible.
Funding & project length: Not stated.
Award mechanism: Milestone-driven cooperative agreement.
Key dates: Not stated.
Best fit for: Device developers and biotech SBCs pursuing clinical translation in neuroscience, addiction treatment, diagnostics, and digital/wearable health technologies.

Key Facts

Deadline

—

Posted

Wed, May 28, 2025

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93.865

Grants.gov

Keywords

medical device development

diagnostic devices

therapeutic devices

wearable technology

digital health tools

imaging biomarkers

in vitro diagnostics

implantable systems

neurotechnology

addiction treatment

regulatory affairs

translational research

clinical trials

non-invasive monitoring systems

Research Areas

OpenAlex

Life SciencesD1Physical SciencesD3Health SciencesD4

Fields

Computer ScienceF17EngineeringF22Immunology & MicrobiologyF24Materials ScienceF25MedicineF27NeuroscienceF28Pharmacology, Toxicology & PharmaceuticsF30Health ProfessionsF36

Subfields

Biomedical EngineeringS2204Health InformaticsS2718Infectious DiseasesS2725NeurologyS2728OncologyS2730Public Health & Occupational HealthS2739Radiology, Nuclear Medicine & ImagingS2741Cellular & Molecular NeuroscienceS2804ToxicologyS3005PharmacyS3611Physical Therapy, Sports Therapy & RehabilitationS3612

Topics

Advanced MRI Techniques and ApplicationsT10378Medical Imaging Techniques and ApplicationsT10522Ethics in Clinical ResearchT10582Telemedicine and Telehealth ImplementationT10912Optical Imaging and Spectroscopy TechniquesT109773D Printing in Biomedical ResearchT11190Non-Invasive Vital Sign MonitoringT11196Microfluidic and Bio-sensing TechnologiesT11255+13 more

MeSH

DiseasesC

Nervous System DiseasesC10Immune System DiseasesC20

Chemicals & DrugsD

Biomedical MaterialsD25Pharmaceutical PreparationsD26

Analytical/Diagnostic/Therapeutic TechniquesE

DiagnosisE01TherapeuticsE02Surgical ProceduresE04Investigative TechniquesE05Equipment & SuppliesE07

Phenomena & ProcessesG

Cell PhysiologyG04Genetic PhenomenaG05

Disciplines & OccupationsHTechnology/Food/BeveragesJ

Health CareN

Health Care ServicesN02Health Care EconomicsN03Health Care Quality & EvaluationN05

ANZSRC FoR

Biomedical & Clinical Sciences32

Clinical Sciences3202Medical Biotechnology3206Neurosciences3209

Engineering40

Biomedical Engineering4003Materials Engineering4016

Health Sciences42

Health Services & Systems4203Public Health4206Sports Science & Exercise4207

Information & Computing46

Data Management & Data Science4605Human-Centred Computing4608

Gotcha Warnings are heuristic flags for further investigation — not a compliance check. Always read the full FOA/NOFO.

Gotchas (2)

Soft Block

eligibilityeligibility pi career stage

New/Early-Stage Investigator Restriction

Rule

100%

Source Text

“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.”

Warning

planningaward mechanism instrument

This is a milestone-driven cooperative agreement program requiring NIH program staff participation in negotiating the final project plan before award and monitoring research progress—a more intensive

85%

Source Text

“This is a milestone-driven cooperative agreement program and will therefore involve participation of NIH program staff in negotiating the final project plan before award and monitoring research progress.”

Synopsis

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage eligible small business concerns (SBCs) to pursue translational activities and clinical studies to advance the development of technologies to prevent, monitor, diagnose, and treat disorders within the missions of participating Institutes, Centers, and Offices. The NOFO will include participation from trans-NIH initiatives including the Blueprint for Neuroscience Research, the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, and The Helping to End Addiction Long-term (HEAL) Initiative. Technologies responsive to the program may include diagnostic, therapeutic, rehabilitative, and/or monitoring devices including wearables, digital health tools, imaging-based biomarkers, in vitro diagnostics, medical-device-development-tools (MDDT), implantable or non-invasive systems, clinical tools, and other device-related technologies. 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. Clinical studies and trials addressing safety, usability, feasibility, and/or efficacy of these technologies would also be included. This is a milestone-driven cooperative agreement program and will therefore involve participation of NIH program staff in negotiating the final project plan before award and monitoring research progress. Participants in the program will receive funding for all activities to be conducted in their own laboratories. In addition, applicants may request support to collaborate with consultants to receive assistance with specialty areas including regulatory, reimbursement, intellectual property, commercialization, and strategic partnerships. Participants can also request access to contract services that specialize in animal testing, sterilization, biocompatibility, manufacturing, and clinical support/medical monitoring. SBCs developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this NOFO.

Source: Simpler.grants.gov