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RIVANNA expands multi-site clinical study for Accuro XV musculoskeletal imaging system

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.

“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.

Learn more here.

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