AIR Frequently Asked Questions (FAQs)

To avoid conflicts of interest, particularly between TA1-A (robotic systems) and TA1-B (simulation platforms for robot evaluation), and to ensure high quality solutions across the program, the following eligibility rules have been established.

The maximum number of full proposals a team may be part of is three (3): one (1) as prime and two (2) as subcontractor, or three (3) as subcontractor. A team may be the prime for TA1 and a subcontractor for TA2 and vice versa. A team may not be the prime for TA1-A and a subcontractor for TA1-B, or vice versa.

Given that there will be down-selection between the solution summary and full proposal stages, a team may submit solution summaries as a prime for TA1-A/B while a subcontractor on another TA1-B/A solution summary. However, for full proposals, a team must choose between TA1-A and TA1-B.

For universities, a team is generally a lab or collaborative group. Two distinct labs with different PIs are likely to be considered different teams.

For businesses, a team is typically a legal distinct entity with its own Unique Entity Identifier (UEI). Two independent subsidiaries of the same parent company (different UEIs) may apply to/be awarded as prime on TA1-A and TA2, or to TA1-B and TA2. Two independent subsidiaries of the same parent company (different UEIs) may not be awarded on both TA1-A and TA1-B.

If a subcontractor acts as a neutral vendor on a proposal rather than as key personnel, they may at ARPA-H’s discretion be exempt from the three-proposal limit. In this case, proposers should consider engaging with multiple vendors.

There is no requirement for the number of teams partnering on a given proposal; rather, team organization should be governed by the ability to effectively fulfill the requirements of the solicitation.

For more unique or complex scenarios, ARPA-H reserves the right to assess team structures and individual roles across submissions to address any actual or perceived conflicts of interest.

International institutes that are not designated a Foreign Country of Concern are welcome to participate. For additional information, please see the General Submission FAQs in the Submission Resources section of the website.

At the Solution Summary stage, overlap is allowed. However, once full proposals are submitted, key personnel (including advisors) cannot be on both TA1-A and TA1-B at the time of award, in addition to overall team participation limits.

All conforming Solution Summaries will be provided feedback; however, the level of detail may vary depending on the number of submissions and whether a Solution Summary is encouraged or discouraged.

Solution Summaries and proposals must address all requirements described in the solicitation. Partnerships are encouraged as a way of meeting all requirements; the Teaming Page lists teams that have indicated an interest in partnering.

The three (3) proposal limit applies to full proposals.

If a team member is a part of a Malign Foreign Talent Recruitment Program (MFTRP), they will be prohibited from participating or being included as personnel on any ARPA-H proposal. If the team member is a part of the company but not a member of the proposal, the company will need to provide a risk mitigation plan on how the ARPA-H data will be firewalled to prevent disclosure to the MFTRP employee and the foreign country of concern.

Any organization member can submit the proposal on behalf of the team.

Endovascular navigation is a fundamental component of TA1. Non-vascular elements may be considered in addition to, but not in place of, endovascular navigation. Similarly, ischemic stroke (large vessel occlusions) and embolization treatments are also fundamental aspects of TA1. Additional endovascular therapies may be considered in addition to, but not in place of, mechanical thrombectomy and neurovascular embolization. 

Novel ideas outside of this scope may be submitted through other ARPA-H mechanisms, such as the Innovative Solution Openings (ISO).

TA1-A involves robotic systems to autonomously guide endovascular devices, and system specifications such as size, weight, footprint, etc. must be described as part of the proposal. Excessively large systems may be impractical to deploy in rural settings and thus may not meet the requirements of the program. Developments specific to attaining vascular access are out of scope. TA1 is independent of TA2, and for TA2 proposers are to select a surgical intervention and detail a microbot solution for it.

It is expected that teams selected for TA1-B will be responsible for obtaining neurovascular procedure data and furnish them to TA1-A teams. However, it is understood that TA1-A teams may need to perform some data collection activities independently.

While thrombectomy is the most pressing unmet need, the platform is intended to be applicable across a range of endovascular procedures, including embolization. Within the thrombectomy case, embolization may be necessary to address vessel perforation.

While the platform is intended to be applicable across a range of endovascular procedures, thrombectomy is the most pressing unmet need, likewise the robot should be able to perform embolization in the brain.

The intervention should be autonomous following vascular access through to the final withdrawal of devices, before vessel closure. Vascular access and closure themselves are out of scope and may be performed by a human. The guidewire should be positioned and manipulated by the robot, without human assistance.

Standalone clot removal and embolization procedures should be automated. If embolization is performed as part of an emergency solution for thrombectomy, human input is allowed and must be conveyed clearly by the robot to attending medical personnel. The endovascular surgeon is not required to assist the robot.

The minimum vessel size is approximately 2 mm, corresponding to the smallest available catheter.

Templates and scaffolds will be developed to standardize testing and facilitate review. These will be provided in digital form (e.g., CAD files, material composition, etc.) to performers. Parameters may be adjusted as the program progresses, and meetings between performer teams and the FDA team will be used to finalize designs.

Coordination between the various aspects of the TA1 arms will be required.

Formal, thorough integration with imaging systems is preferred, ideally through partnerships with imaging companies as opposed to e.g., aftermarket workarounds. Access to relevant software is necessary.

Early milestones require networked teleoperation, but not necessarily long-distance teleoperation. Hardwired setups are acceptable for initial demonstrations, but networked teleoperation over ubiquitous networking technology (i.e., Wi-Fi) is ultimately required.

An ultimate end goal would be to eliminate radiation from fluoroscopy. Cart-sized alternatives are acceptable for development. Large imaging or tracking systems such as MRI are not in scope.

Target the technology that works best for your goals. A bridge study against the FDA-approved version may facilitate clearance.

TA1-B aims to standardize simulation software and facilitate comparison between different approaches. TA1-A teams will have access to these models for evaluation later in the program, so it is expected that TA1-A teams will need their own simulation software to meet earlier milestones.

Real. Angiographies already exist as real datasets and can be used retrospectively. Other datasets (such as intraprocedural fluoroscopies) may require partnerships and will likely need to be acquired prospectively.

Datasets acquired during the AIR program will become public. TA1-B performers are responsible for identifying sources of data, acquiring it, and making it publicly available.

All requirements are listed in the ISO. If proposing additional data types, including any applicable temporal information, describe the value of such data to the program.

Multiple imaging modalities, or data acquired from different sessions on different days, from a single patient count as multiple datasets. Same-day data of the same modality count as one dataset.

It is anticipated that data-driven, simulated, and/or explicit modeling could be involved, but it is up to proposers to specify a promising solution for meeting the requirements and achieving program goals as set forth in the ISO.

Off-unit sources of locomotion and localization are permitted provided that surgical intervention end goals are achieved in a productive manner, i.e., providing clear benefits to patients, clinicians, and other relevant stakeholders. Note that external equipment should not be so onerous as to defeat the purpose of microbots.

If a microbot is tethered, traverses the vascular system, and treats stroke to a degree similar or superior to mechanical thrombectomy, it may be suitable for TA1-A. Note however that it must also be capable of neurovascular embolization. Otherwise, TA2 may be more appropriate.

Living cells hybridized with synthetic/non-biological components would be considered responsive to the TA2 call.

GI microrobots are not required to be ingestible.

Nanoparticles, often called nanobots, are not in scope, but will be considered provided the solution includes an electrical or mechanical component that carries out required microbot functionality.

Yes.

If it provides material benefit to the approach proposed, then simulation, modeling, and validation is viewed favorably and can be included. Should reviewers deem such efforts as unnecessary or overly expensive relative to the overall thrust of the project, they may request that the work be rescoped or deemphasized.

Yes, this is in scope subject to the GI pill robot exclusions noted in the ISO.

Microbubbles are not considered microbots under this program.

Yes, delivery via a robot will be considered.

Alternative approaches such as optical sensing must be strongly correlated with pathological readings to be considered equivalent to a physical biopsy. End-to-end solutions are required beyond imaging alone.

This is not an imaging program. While imaging technology optimization may be necessary and supportive to program goals, proposals focused primarily on imaging do not meet program requirements.

Some external aids for sensing are permitted, but the microbot should have sensing capability. If in doubt, submit your solution for review.

If a tether is used only for the simpler portions of the navigation and the robot navigates to hard-to-reach locations on its own, it may be considered. The microbot must add unique value beyond standard tethered or catheter-based approaches. Make a case for your approach.

Imaging for GI microbots is not specifically excluded but cannot be the only capability. Imaging-centric proposals alone are not responsive.

Yes, but the same requirements for post-intervention microbot evacuation/elimination apply and the approach should not significantly increase procedure time and complexity over a monolithic microbot approach.

Microbots must be able to move, sense, and act. While neurostimulation is in scope for the ‘act’ requirement, devices that cannot move and sense (e.g., devices that resemble implants) are not.

Pre-operative imaging is allowed to facilitate microbot navigation.

Although C-arms are not strictly forbidden due to cart-sized portability, please consider that they introduce other requirements such as radiation shielding and facilities provisioning that detract from the intent of TA2.

FDA engagement as described in the ISO is specific to TA1.

Yes, provided that the larger size is within reason and there is a feasible path toward miniaturization to meet requirements.

ARPA-H expects to make awards using Other Transactions (OTs) for flexible, milestone‑based research and development agreements, as described in the solicitation. These are not traditional grants or standard procurement contracts and allow ARPA-H to tailor terms and conditions to the specific project.

ARPA-H does not prescribe a strict budget cap for this program. Proposers should submit a budget that is realistic and well-justified for accomplishing the proposed work and meeting the program metrics and milestones. Selection decisions will consider the availability of funds, the quality of proposed solutions, and the reasonableness of proposed costs, as described in the solicitation. To help assess cost realism and how efforts align with the technical plan, the proposed budget should identify labor categories and distribute costs across project years.

There is no predetermined number of awards per Technical Area. The number of awards will depend on the quality of proposals received, how well they address the program objectives and metrics, and the availability of funds. There may be multiple awards, a single award, or no awards in each TA, as described in the solicitation. Proposers should focus on submitting the most compelling, high‑impact solution they can, rather than targeting a specific number of anticipated awards.

The ISO includes down‑selection at phase transition points. At these points ARPA‑H may: (1) continue funding, (2) re‑scope or redirect work, and/or (3) discontinue funding teams or project elements based on performance against metrics and overall program needs. Down‑selects are not limited to all‑or‑nothing outcomes for entire teams.

A 20% cost share is strongly encouraged, especially for TA1-A, but it is not mandatory. Proposals without cost share will still be considered. Cost share may be proposed as Cash (e.g., non-federal funds for allowable project costs) or In-Kind (e.g., contributed equipment, space, or labor), consistent with the ISO, and must be reasonably valued, clearly documented, and verifiable.

Tuition remission is negotiable and not always guaranteed, but students may participate and be paid from the OT.

Under OTs, you typically retain rights to background IP and ownership of IP developed during the period of performance, while the Government generally receives certain license rights. Specific IP terms, including the scope of Government rights, are negotiated prior to award and may vary by agreement. Note that OTs can be more flexible than traditional contracts.

Disclose preexisting IP and create an IP management plan from the outset. If invited to submit a full proposal, be clear about which elements will involve your existing and to-be-developed IP.

No. ARPA‑H typically structures OTs as milestone‑based, fixed‑amount research and development agreements. Payments are generally tied to the successful completion of predefined technical milestones and deliverables, rather than to the reimbursement of actual incurred costs. Please refer to the ISO for detailed instructions. Final payment terms will be negotiated with selected performers. For general information on OTs at ARPA-H, please see the OT Community page.

It is typically the responsibility of the prime proposer to determine suitable arrangements with subs.

The proposed budget should account for the full period of performance.

A full proposal must be associated with its preceding Solution Summary, and the two submissions must correspond substantially. Changes to key elements must be conveyed and detailed to ARPA-H and may be permitted at ARPA-H’s discretion.

Hyperlinks are allowed in the Solutions Summary and full proposal; however, all material to be evaluated must be contained within the submitted documents and reviewers are not obligated to consider any material referenced elsewhere.

The submission deadlines were updated through a formal amendment to the solicitation on SAM.gov to address programmatic and administrative needs. All materials were then updated as quickly as possible. During this transition period, there may have been a short time when public-facing pages and the solicitation (ISO) did not yet match.

No. ARPA-H will conduct the ELSI analysis and provide results to awardees.

As productization progresses, such partnerships may be established via governmental resources, but specific arrangements will be defined as the program evolves.

ARPA-H focuses on development as opposed to policy mandates. ELSI analysis is intended to identify and address roadblocks early, but mandates are beyond the scope of ARPA-H.