Translational Devices

General Information

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Chart displays the Translational Devices program provides support for the development, optimization, translation, and first-in-human testing of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems

The Translational Devices program provides support for the development, optimization, translation, and first-in-human testing of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. The program consists of funding opportunities for investigator-initiated projects at NINDS (RFA-NS-21-021 / RFA-NS-21-022) and through related trans-NIH programs.

Companion Trans-NIH Device Programs

Blueprint MedTech

The overarching goal of the Blueprint MedTech program is to accelerate patient access to groundbreaking, safe, and effective medical devices. The program supports the translation of groundbreaking neurotechnologies from early stages through first-in-human studies by providing non-dilutive funding and additional resources to de-risk and develop therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems.

For more information visit the Blueprint MedTech website.

Open Funding Announcements

Closed Funding Announcements

Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative

The Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System program encourages applicants to pursue milestone-driven translational and clinical projects for implantable recording and/or stimulating devices to treat central nervous system (CNS) disorders and better understand the human brain.

For more information visit the BRAIN Initiative website.

Open Funding Announcements

  • NOT-NS-22-052 - Notice of Special Interest in the Blueprint MedTech program
  • RFA-NS-21-023 (UG3/UH3) - Translation of Next-Generation Invasive Devices
  • RFA-NS-21-024 (UH3) - Clinical Studies of Next-Generation Invasive Devices

Closed Funding Announcements

Helping to End Addiction Long-Term (HEAL)

The Translating Discoveries into Effective Devices to Treat Pain program fosters the development of next-generation medical devices to diagnose and treat pain by supporting preclinical development of safe, effective, and non-addictive devices and approaches – providing treatment options for those who have no other effective ways to manage their pain. The program also supports the translation of promising devices into early-stage clinical trials that inform the functionality, final design, safety, and/or efficacy of technologies. In addition, the program supports interdisciplinary team science to reveal mechanisms underlying device-based pain relief, identify physiological markers of pain, and determine how existing device-based therapeutic approaches affect neural targets.

For more information visit the HEAL Initiative website.

Open Funding Announcements

  • RFA-EB-22-002 (R18) - Development of Diagnostic and Therapeutic Devices
  • NOT-NS-23-002 (UG3/UH3 and U44) - Notice of Special Interest in the Blueprint MedTech program
  • RFA-NS-23-003 (RM1) - Team Science Research on Device Mechanisms

Closed Funding Announcements

Education Program on Translational Devices

The purpose of this program is to develop and implement a short course focused on (1) steps required for successful neural medical device development, translation, and commercialization, (2) common technical and strategic challenges, and (3) best-practices and resources for each stage in the process.

Closed Funding Announcements

Program Snap Shots

NINDS Translational Neural Devices

  • Clinical Study Optional
  • Invasive or noninvasive
  • CNS or PNS
  • Diagnostic or Therapeutic
  • Within NINDS Mission
  • Budgets should rarely exceed:
    • UG3: $1M DC/yr
    • UH3: $1.5M DC/yr
    • U44 Phase I: $1M TC/yr
    • U44 Phase II: $1.5M TC/yr

BRAIN Initiative Next Generation Devices

  • Clinical Study Optional
  • Invasive only
  • CNS only
  • Diagnostic or Therapeutic
  • Within mission of a BRAIN IC
  • Budgets:
    • UG3/UH3: No budget limit


       

  • All funding opportunities for investigator-initiated projects use cooperative agreement mechanisms and are milestone-driven. This type of mechanism involves NIH program staff's participation in developing the project milestones and plans, monitoring the research progress, and making go/no-go decisions.
  • For projects that have completed all non-clinical testing necessary to obtain an IDE or obtained NSR designation from a local IRB, straight to clinical options (UH3 and SBIR U44 Phase II) are available in the BRAIN Initiative.
  • Phased cooperative agreement mechanisms (UG3/UH3 and SBIR U44 Fast-Track) support pre-clinical/translational device activities, including translational bench and animal studies, and are expected to lead to an Investigation Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to support a small clinical trial, or a Non-Significant Risk (NSR) designation from an Institutional Review Board (IRB) in the first phase. The subsequent phase supports the small clinical study or trial to collect safety and effectiveness data required to support a marketing application, or to inform final device design.
  • For UH3 awards, IRB/FDA approval is required prior to issuance of the NOA. For UG3/UH3 and U44 awards, IRB/FDA approval is required prior to release of funds for the clinical studies.

All Applicants are strongly encouraged to contact translational devices staff at least two months prior to the receipt date.

Resources and Tools

Contacts

Funding Opportunities 

View All Translational Research Opportunities

 

Related Topics 

FAQs

Milestones

Regulatory Guidance