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Small Business Translator: MedTech and Digital Health Technologies
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Service Source Final Application Due Date Funding Available Match Required
Health Care Federal
HHS
10-20-2025 N/A No Match
Required
  • Service
  • Source
  • Final Application Due Date
  • Funding Available
  • Match Required
Status
  • Past
  • Current
  • Forecasted
    • Opportunity Type Discretionary
    • CFDA

      93.121 -- Oral Diseases and Disorders Research

      93.213 -- Research and Training in Complementary and Integrative Health

      93.242 -- Mental Health Research Grants

      93.273 -- Alcohol Research Programs

      93.279 -- Drug Use and Addiction Research Programs

      93.286 -- Discovery and Applied Research for Technological Innovations to Improve Human Health

      93.372 -- 21st Century Cures Act - Brain Research through Advancing Innovative Neurotechnologies

      93.853 -- Extramural Research Programs in the Neurosciences and Neurological Disorders

      93.865 -- Child Health and Human Development Extramural Research

      93.866 -- Aging Research

      93.867 -- Vision Research

    Description

    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 efficacyof 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.

    Eligibility
    • IHE
    • Local Government
    • Non-Profit
    • Other
    • State Government
    • Tribal Government
    Key Date(s)
    • May 28, 2025: Last Updated Date
    • May 28, 2025: Forecasted Date
    • July 21, 2025: Estimated Post Date
    • October 20, 2025: Estimated Application Due Date
    • July 01, 2026: Estimated Project Start Date
    • July 01, 2026: Estimated Award Date
    Contact Information
    Nicholas Langhals, PhD National Institute of Neurological Disorders and Stroke (NINDS) 301-435-0090 Blueprint-MedTech@nih.gov

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