NIH NHLBI Catalyze Medical Device Prototype Optimization – RFA-HL-26-020

NIH/NHLBI is accepting applications for advanced medical-device prototype optimization for heart, lung, blood, and sleep diseases. The next application deadline is October 21, 2026 at 5:00 PM local time of the applicant organization.

FundingUp to $300,000 in direct costs per year for up to two years. NHLBI expects up to eight new awards per fiscal year across this and companion Catalyze NOFOs.

DeadlineOctober 21, 2026 at 5:00 PM local time of the applicant organization. Additional recurring due dates remain in 2027.

Last verifiedOctober 6, 2026

Required next actionConfirm applicant eligibility and registrations, prototype maturity and preliminary evidence, qualified research leadership, intellectual-property and regulatory strategy, required Accelerator Partner support, and the expected non-Federal matching commitment before preparing an October 21, 2026 submission.

Broad Eligibility

Broad domestic eligibility includes higher education, nonprofits, small businesses and other for-profits, state/local/Tribal governments, independent school districts, and other listed U.S. entities. SAM/UEI, Grants.gov, and eRA Commons registrations are required. NHLBI states cost matching is expected and recommends a minimum 0.25:1 non-Federal cash match. At least one Accelerator Partner and its letter of support are required.

Atlas Analysis

The National Heart, Lung, and Blood Institute (NHLBI) is accepting applications for Catalyze Product Definition – Medical Device Prototype Optimization under RFA-HL-26-020. This R33 program supports advanced prototype testing and design modification, diagnostic-assay development, and research-tool development for heart, lung, blood, and sleep diseases and disorders. Clinical trials are not allowed.

Application budgets may request up to $300,000 in direct costs per year for a maximum project period of two years. NHLBI expects to fund up to eight new awards per fiscal year across this NOFO and its companion Catalyze opportunities, subject to appropriations and meritorious applications.

Eligible applicants include U.S. higher education institutions, nonprofits, small businesses and other for-profit organizations, state and local governments, Tribal entities, independent school districts, and other listed domestic organizations. SAM/UEI, Grants.gov, and eRA Commons registrations are required, and all PD/PIs must have eRA Commons accounts.

Deadline: The next application due date is October 21, 2026 at 5:00 PM local time of the applicant organization. Additional recurring due dates remain available in 2027 under the controlling NOFO.

Atlas rates the Nonagon N9+ fit at 94/100, conditional. The opportunity directly supports activities such as system integration, packaging optimization, engineering optimization, performance comparison, verification and validation, design for manufacturing, and regulatory planning. A legitimate N9+ project would need a clearly defined NHLBI-mission heart, lung, blood, or sleep indication and documented prototype readiness. General commercial deployment or a clinical trial would not be responsive.

NHLBI states that cost matching is expected and recommends a minimum 0.25:1 non-Federal cash match of requested Federal direct costs. Applicants must document matching contributions, and evidence of at least one Accelerator Partner is required. A direct Dr. Miltie pursuit is not being advanced unless the matching commitment is approved and project-specific prototype maturity, preliminary evidence, research leadership, IP and regulatory strategy, and Accelerator Partner support are verified.

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