BARDA Seeks SI-Enabled Ultrasound Devices for Point-of-Care Fracture Detection

What Technologies Is BARDA Seeking?

BARDA seeks standalone, point-of-care ultrasound devices that help clinicians visualize or detect musculoskeletal injuries without relying on traditional X-ray or CT infrastructure. The focus includes traumatic injuries resulting from blast events, structural collapse, and other mass casualty scenarios where imaging resources may be unavailable or overwhelmed.

The notice uses “Super Intelligence,” or SI, for technologies commonly known as artificial intelligence and directs respondents to use the same terminology in their submissions.

Capabilities of interest include:

• Automated imaging and bone identification: Volumetric ultrasound capture and anatomical display to support fracture evaluation in areas such as wrists and ankles.

• Embedded SI and machine learning: Models that assist image acquisition, segmentation, and interpretation, with defined sensitivity and specificity and validation against independent datasets.

• Injury characterization: Established or developing capabilities to distinguish fracture types and severity, edema, and soft tissue injuries where clinically appropriate.

• Three-dimensional visualization: Rotatable models and cross-sectional review of captured anatomy to support clinician assessment.

• Comparative performance evidence: Data comparing device performance with established imaging technologies, including X-ray and CT.

The notice calls for models whose performance improves upon that of human imaging experts and requests information on performance reviewed through Food and Drug Administration (FDA) 510(k) submissions. Respondents should distinguish completed capabilities from demonstrable work in progress.

Device Design and Deployment Priorities

BARDA is interested in portable, durable systems suited to both routine clinical care and disaster response. Desired characteristics include integrated SI processing, self-contained imaging supplies, battery operation suitable for austere environments, and functionality without reliable network connectivity.

Devices should require minimal training for nonspecialist operators and fit emergency department, urgent care, and mass casualty triage workflows. BARDA also seeks information on electronic health record interoperability, secure data handling, and applicability across adult and pediatric populations, fracture types, and anatomical locations.

What Should Responses Include?

The notice requests separate technical and business representations from both small businesses and other-than-small businesses.

The technical response should summarize:

• Diagnostic capabilities, supporting performance data, and development status.

• Clinical, bench, and human factors testing.

• Regulatory status, FDA interactions, and the proposed clearance or approval strategy.

• Domestic manufacturing capacity, quality systems, supply chain resilience, and inventory management.

• Cybersecurity, patient information safeguards, and key technical risks.

The business response should address company capabilities, manufacturing and distribution capacity, current or anticipated pricing, purchase or lease options, market outlook, and plans for adoption across clinical settings. This information will help BARDA assess potential procurement approaches, including arrangements that combine device access with maintenance and readiness support.

How to Respond

Submit responses to Sources Sought Notice BARDA-FY27-10192026 by email to [email protected] and [email protected] no later than November 18, 2026, at 1:00 PM ET. Technical and business sections are each limited to 10 single-sided pages, including supporting materials. Refer to the official notice for complete response instructions.