NIH NHLBI Catalyze Medical Device Prototype Design/Testing – RFA-HL-26-019

The National Heart, Lung, and Blood Institute (NHLBI) is accepting applications for Catalyze Product Definition – Medical Device prototype design/testing and disease target identification and assay development under RFA-HL-26-019. This phased R61/R33 program supports early translational development and testing of medical-device prototypes, diagnostics, and research tools for heart, lung, blood, and sleep diseases and disorders. Clinical trials are not allowed under this NOFO.

Application budgets may request up to $300,000 in direct costs per year during the R61 phase and $300,000 per year during the R33 phase. The combined project period may be up to three years, with no more than two years in either phase. 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. Required registrations include SAM/UEI, Grants.gov, and eRA Commons. 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 90/100, conditional. A legitimate project could focus on a defined NHLBI-mission heart, lung, blood, or sleep use case involving guided remote physical examination, vitals or cardiopulmonary data capture, device integration, usability, engineering optimization, verification/validation, or wireless/EHR data integration. A general commercial deployment would not be responsive; the application needs a specific research and product-development aim, biological rationale, milestones, and appropriate IP/regulatory planning.

For transition to the R33 phase, NHLBI expects satisfactory R61 milestone progress, an Accelerator Partner, and evidence of non-Federal cash matching support. The NOFO recommends at least a 0.25:1 non-Federal cash match of requested R33 Federal direct costs. Because Dr. Miltie-specific prototype evidence, research leadership, IP/regulatory posture, and later-stage matching readiness have not been verified, Atlas is treating this as a conditional direct/partner opportunity rather than an approved direct submission.