Rivanna has received clearance from the US Food and Drug Administration (FDA) for its Accuro XV system, an AI-enabled musculoskeletal imaging platform designed for fracture detection and soft tissue injury assessment.

The Virginia-based company said the clearance paves the way for commercial deployment of the system across hospitals and medical clinics in the United States.

Accuro XV combines ultrasound-based bone and three-dimensional soft tissue imaging with artificial intelligence-driven software to automate the detection and volumetric assessment of skeletal fractures and soft tissue injuries. 

The system is designed for use at the point of triage to help streamline emergency department workflows, accelerate evaluation of low-severity extremity injuries, and reduce reliance on X-ray referrals.

According to Delphine Le Roux, Senior Director of Market Access and Strategic Partnerships at Rivanna, the FDA clearance marks an important milestone for expanding the AI capabilities of Accuro XV and unlocking its broader diagnostic potential.

Rivanna recently published findings from a feasibility study of Accuro XV in the Journal of Emergency Medicine. Conducted at UVA Health and UT Southwestern Medical Center, the study involved 205 patients and reported that more than 90 percent of scans were considered adequate for diagnostic interpretation across operator groups.

Will Mauldin, CEO of Rivanna, said the approval demonstrates the scalability of the company’s imaging hardware, AI architecture, and regulatory platform across multiple clinical applications, positioning the company to help redefine extremity injury triage in emergency care.