Company accelerates AI-enabled fracture detection development, compressing anticipated FDA 510(k) timeline

CHARLOTTESVILLE, Va., April 22, 2026 /PRNewswire/ — RIVANNA^®, developer of AI-enabled clinical decision-support solutions, announced that it has expanded its clinical studies evaluating Accuro^® XV, the company’s musculoskeletal imaging system, from two to eight sites nationwide. This expansion follows execution of a funding option by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).

The study will support development of the first-ever automated fracture detection algorithm derived from volumetric ultrasound imaging. RIVANNA’s computer-aided detection (CADe/x) technology will be trained on extensive upper and lower extremity injury 3D imaging datasets collected across eight clinical sites — a foundational capability unprecedented in musculoskeletal imaging. The study will also conclude validation and training of BoneEnhance^®, an image segmentation module that enhances bone visualization and represents an incremental step toward the company’s full diagnostic platform.

Renowned principal investigators at eight study sites are participating in the nationwide study:

Expert emergency physicians with nearly a century of combined experience across the country are enthusiastic about participating in the study to evaluate an alternative technology that could transform delivery of care in emergency medicine. Denver Health, including Denver Health’s Emergency Department, and the Denver Health Winter Park Medical Center locations (Matthew Riscinti, MD); Texas Tech Health El Paso (Edward Michelson, MD); University of California, San Francisco (Aaron Kornblith, MD, MS); University of Utah (Christopher Kelly, MD); UVA Health (Christopher Thom, MD, RDMS); UT Southwestern Medical Center (Philip Jarrett, MD, MBA); Virginia Commonwealth University (Jordan Tozer, MD, MS, FAEMUS); and Yale University (Cristiana Baloescu, MD, MPH).

This study will build a required database of a variety of clinical images to train the algorithm CADe/x AI-enabled fracture detection capability and to validate BoneEnhance, representing key milestones toward RIVANNA’s full diagnostic platform.

“Now that all eight clinical sites are actively enrolling patients, development of AI for fracture detection is anticipated to compress the 510(k)-submission timeline,” said Delphine Le Roux, PhD, PMP, Senior Director, Market Access and Strategic Partnerships at RIVANNA. “Expanding our clinical program from two to eight sites in four months, with a total of 10 systems deployed, is a testament to our strong partnerships, as well as our team’s agility and capabilities. Our ability to rapidly activate clinical sites reflects the trust and engagement we’ve built with leading academic medical centers over the years, partnerships that are essential to advancing this technology.”

“Enhancing Accuro XV with features that highlight fractures represents the next major advancement in point-of-care imaging,” said Christopher Thom, MD, RDMS, Associate Professor of Emergency Medicine at the University of Virginia School of Medicine and principal investigator for the study. “We’re developing the first automated fracture-detection capability derived from volumetric imaging — a breakthrough that has the potential to transform how extremity injuries are evaluated at the bedside. And as we scale this study, we’re also seeing positive signals around patient comfort,” added Dr. Thom.

Beyond building the datasets required for AI development, the expanded study is generating early clinical insights: Preliminary analysis found that among patients who did not receive pain medication (33.6% of the 666 enrolled), Accuro XV imaging was associated with significantly less increase in pain compared to X-ray (mean change: -0.09 vs. +0.36; p<0.001). These findings, not yet published, suggest potential patient experience benefits that complement the system’s diagnostic capabilities.

About Accuro XV

Accuro XV is a portable, small-footprint point-of-care volumetric ultrasound imaging system for musculoskeletal imaging. The system features a conformable three-dimensional probe that automates large field-of-view B-mode image acquisitions without ionizing radiation. With AI-enabled decision-assist capabilities advancing toward FDA clearance, Accuro XV will deliver BoneEnhance, a machine learning software module that segments musculoskeletal anatomy to support 3D visualization of skeletal structures, and a CADe/x software module that uses machine learning to assist clinicians in detecting fractures from volumetric ultrasound imaging to support triage decisions, including referral for additional radiographic imaging.

Accuro XV is designed to provide a fracture-care layer at the point of triage — helping to streamline emergency department workflows, expedite evaluation of low-severity extremity injuries, and reduce reliance on X-ray referrals. The platform is designed to support just-in-time training to promote consistent use across clinical experience levels, advancing a shared mission to transform musculoskeletal injury care while supporting broader emergency preparedness objectives.

This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; the Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50121C00035.

About RIVANNA

RIVANNA® is a medical technology company developing clinical decision-support solutions powered by proprietary clinical datasets, AI models, and purpose-built imaging hardware. The company’s platform automates complex anatomical analysis at the point of care, enabling faster, more confident clinical decisions while reducing variability and expanding access to advanced capabilities. The first applications target significant market opportunities in regional anesthesia and fracture care. Backed by 100+ patents, both products are on FDA 510(k) pathways and validated across multiple academic medical centers. RIVANNA is headquartered in Charlottesville, Virginia, and operates an FDA-registered, ISO 13485:2016-certified manufacturing facility.

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SOURCE RIVANNA