Small Business Translator: MedTech and Digital Health Technologies

id: 359156
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opportunityNumber: FOR-NS-25-017
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opportunityTitle: Small Business Translator: MedTech and Digital Health Technologies
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revision: 0
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agencyDetails: {"code":"NIH","seed":"HHS-NIH11","agencyName":"National Institutes of Health","agencyCode":"HHS-NIH11","topAgencyCode":"HHS"}
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owningAgencyCode: HHS-NIH11
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cfdas: [{"id":428647,"opportunityId":359156,"cfdaNumber":"93.121","programTitle":"Oral Diseases and Disorders Research"},{"id":428648,"opportunityId":359156,"cfdaNumber":"93.213","programTitle":"Research and Training in Complementary and Integrative Health"},{"id":428650,"opportunityId":359156,"cfdaNumber":"93.242","programTitle":"Mental Health Research Grants"},{"id":428643,"opportunityId":359156,"cfdaNumber":"93.273","programTitle":"Alcohol Research Programs"},{"id":428642,"opportunityId":359156,"cfdaNumber":"93.279","programTitle":"Drug Use and Addiction Research Programs"},{"id":428645,"opportunityId":359156,"cfdaNumber":"93.286","programTitle":"Discovery and Applied Research for Technological Innovations to Improve Human Health"},{"id":428646,"opportunityId":359156,"cfdaNumber":"93.372","programTitle":"21st Century Cures Act -\tBrain Research through Advancing Innovative Neurotechnologies"},{"id":428644,"opportunityId":359156,"cfdaNumber":"93.853","programTitle":"Extramural Research Programs in the Neurosciences and Neurological Disorders"},{"id":428651,"opportunityId":359156,"cfdaNumber":"93.865","programTitle":"Child Health and Human Development Extramural Research"},{"id":428649,"opportunityId":359156,"cfdaNumber":"93.866","programTitle":"Aging Research"},{"id":428641,"opportunityId":359156,"cfdaNumber":"93.867","programTitle":"Vision Research"}]
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forecastDesc: <p><span style="color: rgb(51, 51, 51);">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&nbsp;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.</span></p>
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applicantTypes: [{"id":"01","description":"County governments"},{"id":"22","description":"For profit organizations other than small businesses"},{"id":"00","description":"State governments"},{"id":"06","description":"Public and State controlled institutions of higher education"},{"id":"12","description":"Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"07","description":"Native American tribal governments (Federally recognized)"},{"id":"05","description":"Independent school districts"},{"id":"08","description":"Public housing authorities/Indian housing authorities"},{"id":"11","description":"Native American tribal organizations (other than Federally recognized tribal governments)"},{"id":"20","description":"Private institutions of higher education"},{"id":"23","description":"Small businesses"}]
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fundingInstruments: [{"id":"CA","description":"Cooperative Agreement"}]
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fundingActivityCategories: [{"id":"HL","description":"Health"}]
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costSharing: false
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lastUpdatedDate: May 28, 2025 07:57:55 AM EDT
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status: forecasted
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