Small Business Translator: MedTech and Digital Health Technologies

Past Federal grant forecast Posted

Opportunity number
FOR-NS-25-017
Agency
Applications expected due
Award size
Not on record

Opportunity facts

Expected posting
Assistance listings
1 more on GovTribe
Funding instrument
Cooperative Agreement
Category
  • Health
Eligible applicants
  • Small Businesses
  • State Governments
  • Higher Education Inst. (Private)
  • For Profit Organizations
  • 501(c)(3) Nonprofits
  • County Governments
  • Tribal Organizations (Not Federally Recognized)
  • Higher Education Inst. (Public)
  • Public or Indian Housing Auth.
  • Tribal Governments (Federally Recognized)
  • Independent School Districts
Points of contact

Opportunity details come from Grants.gov. Updated .

About this opportunity

Written by GovTribe AI ·

The National Institutes of Health is soliciting cooperative agreement applications from eligible small business concerns and other entities to support translational activities and clinical studies advancing medical device and digital health technologies, with participation from the NIH Blueprint for Neuroscience Research, the BRAIN Initiative, and the HEAL Initiative.

Eligible applicant categories include small businesses, state and county governments, public and private higher education institutions, for-profit organizations, 501(c)(3) nonprofits, tribal governments and organizations, public or Indian housing authorities, and independent school districts. No cost share or matching requirement is stated in the source.

The program funds implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, Investigational Device Exemption (IDE) applications for Significant Risk studies, and Institutional Review Board approvals for Non-Significant Risk studies. Clinical studies addressing safety, usability, feasibility, and efficacy of diagnostic, therapeutic, rehabilitative, and monitoring devices—including wearables, digital health tools, imaging-based biomarkers, in vitro diagnostics, medical-device-development-tools, implantable or non-invasive systems, and clinical tools—fall within scope. Applicants may request support for consultants in regulatory, reimbursement, intellectual property, commercialization, and strategic partnership areas. Participants will receive funding for activities conducted in their own laboratories.

This is a milestone-driven cooperative agreement program requiring negotiation of the final project plan with NIH program staff before award and ongoing monitoring of research progress. The opportunity participates in trans-NIH initiatives spanning neuroscience, brain-mapping technologies, and opioid addiction treatment. The source does not specify an award ceiling, award floor, expected number of awards, period of performance, or application due date. The parent grant programs include Assistance Listing numbers 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 (BRAIN Initiative), and related NIH research mechanisms.

Forecast 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.

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