NHLBI Catalyze RFA-HL-26-019: Product Definition for Medical Devices, Diagnostics and Research Tools

What is the NHLBI Catalyze Product Definition program for medical devices?

The NHLBI Catalyze Product Definition program (RFA-HL-26-019) is an NIH grant from the National Heart, Lung, and Blood Institute that funds early-stage development of medical device prototypes, diagnostic assays, and research tools for heart, lung, blood, and sleep (HLBS) diseases and disorders.

It uses a two-phase R61/R33 structure. The R61 phase supports initial prototype design and testing, disease target identification, and pilot work on research tools. The R33 phase supports continued development, larger-scale testing, and data integration, with the goal of positioning the product for preclinical development such as the NHLBI Catalyze Preclinical Program.

Unlike SBIR and STTR, Catalyze is open to for-profit companies of any size as well as universities and nonprofits, and it puts heavy weight on milestones, regulatory planning, and commercialization partners.

What are the key dates and funding amounts?

• Next recommended deadline: February 11, 2027 (5:00 PM local time of the applicant organization)
• Remaining due dates: October 21, 2026, February 11, 2027, June 17, 2027, and October 21, 2027
• Earliest start dates: July 2027 (October 2026 cycle), December 2027 (February 2027 cycle), April 2028 (June 2027 cycle), July 2028 (October 2027 cycle)
• Budget: up to $300,000 in direct costs per year in both the R61 and R33 phases
• Project period: up to 3 years combined, with no more than 2 years in either phase
• NHLBI plans up to $4,466,000 per fiscal year (FY 2026 through FY 2028) for up to 8 new awards per year across this NOFO and its companion NOFOs
• Notice expires December 24, 2027

Who is eligible to apply?

• For-profit organizations, including small businesses and larger companies
• Public and private institutions of higher education
• Nonprofits, with or without 501(c)(3) status
• State, local, and tribal governments, federal agencies, and certain other organizations

Foreign organizations are not eligible, although non-U.S. components of U.S. organizations are allowed. Any individual with the needed skills and resources can serve as PD/PI, and every PD/PI needs an eRA Commons account. An organization may submit multiple applications if each is scientifically distinct.

What does Catalyze Product Definition fund?

Medical devices

R61 work can include key component testing, a first prototype or benchtop unit, in vitro and acute in vivo testing, and small animal studies. R33 work can include system integration, design for manufacturing, performance comparison against gold standard devices, chronic in vivo and large animal testing, and an FDA pre-submission meeting.

Diagnostics and assays

R61 work can include testing with limited human samples, building a working prototype, and incorporating assays onto an existing sensing platform. R33 work can include validation in large sample panels or clinical datasets, sensitivity and precision improvements, and an FDA pre-submission meeting.

Research tools

R61 work can include algorithm design, smartphone interface development, limited user and focus group testing, and pilot feasibility studies. R33 work can include large population testing, EHR integration, extension to iOS or Android, and multi-site studies.

What is out of scope

• Therapeutic agent development (covered by companion NOFOs RFA-HL-26-017 and RFA-HL-26-018)
• Development of risk, detection, diagnostic, prognostic, predictive, and prevention biomarkers
• Clinical research and clinical trials

How does the R61 to R33 transition work?

Applicants propose two separate sets of quantifiable milestones, one for R61 and one for R33. Milestones must be specific, measurable, and time-bound, and every Specific Aim needs at least one. Specific Aims or activity lists alone do not count as milestones.

NHLBI decides whether to fund the R33 phase based on three factors:

• Achievement of the R61 milestones
• Third-party investment, shown by a recommended minimum 0.25:1 non-Federal cash match of R33 Federal direct costs (in-kind contributions do not count toward the match)
• An Accelerator Partner, a commercialization expert who mentors the team on business development, regulatory submissions, IP, reimbursement, and market analysis

Neither the cash match nor the Accelerator Partner is required at application, but the application must explain how a partner would fill development gaps, and NHLBI expects you to secure one early in the R61 phase.

How do you apply?

• Register your organization in SAM.gov, Grants.gov, and eRA Commons well before the deadline
• Contact NHLBI program staff early to confirm your project fits the HLBS scope
• Build R61 and R33 milestone plans and place the project timeline as the last element of the Research Strategy
• Prepare the required "IP and Regulatory Strategies.pdf" attachment covering IP position, patents, third-party IP limits, and your planned FDA pathway (for example 510(k) or IDE). Applications without it will not be peer reviewed.
• Submit through Grants.gov using NIH application forms by 5:00 PM local time on the due date

Reviewers score importance of the research, rigor and feasibility (including whether milestones are measurable and timelines realistic), and expertise and resources. Applications may be triaged, with only the top half discussed.

Is this a fit for your company?

Catalyze Product Definition suits medtech, diagnostics, and digital health companies with a heart, lung, blood, or sleep application, solid preliminary data, and a clear path to an FDA pathway. It is especially useful for companies that are not SBIR eligible or have already used SBIR, because there is no company size limit. The milestone plan, IP and regulatory attachment, and Accelerator Partner strategy are where many applications win or lose.

BW&CO has helped clients secure $350M+ in non-dilutive funding. Book a free funding fit call and we will tell you whether Catalyze, NIH SBIR, or another program is the strongest route for your technology.

Frequently asked questions

How much funding does NHLBI Catalyze Product Definition provide?

Up to $300,000 in direct costs per year in each of the R61 and R33 phases, over a combined project period of up to 3 years with no more than 2 years in either phase.

When is the next deadline for RFA-HL-26-019?

The remaining due dates are October 21, 2026, February 11, 2027, June 17, 2027, and October 21, 2027, each at 5:00 PM local time of the applicant organization.

Can companies apply, or only universities?

Companies can apply. For-profit organizations of any size, including small businesses, are eligible, along with universities, nonprofits, and government entities. Foreign organizations are not eligible.

Do I need an Accelerator Partner or cost match to apply?

No. Both are needed to transition from R61 to R33, not at application. NHLBI recommends a minimum 0.25:1 non-Federal cash match for the R33 phase and requires an Accelerator Partner before R33 funding.

Does Catalyze fund therapeutics or clinical trials?

No. Therapeutics are covered by companion NOFOs RFA-HL-26-017 and RFA-HL-26-018. Clinical trials, clinical research, and biomarker development are not responsive to this NOFO.

What attachment is required with the application?

An "IP and Regulatory Strategies.pdf" attachment describing your IP position and planned FDA regulatory pathway is required. Applications without it are considered incomplete and will not be peer reviewed.