RIVANNA receives FDA clearance for AI-enabled musculoskeletal ultrasound system

RIVANNA announced that the U.S. Food and Drug Administration has granted 510(k) clearance for the Accuro XV Diagnostic Ultrasound System, allowing the company to commercially market the device for musculoskeletal imaging in hospitals and medical clinics.

The clearance authorizes use of the system by qualified and trained healthcare professionals and marks a key regulatory milestone for the company as it expands its artificial intelligence-enabled imaging platform.

RIVANNA said the Accuro XV is designed as a portable, point-of-care volumetric ultrasound imaging system for musculoskeletal applications. The platform uses a conformable three-dimensional ultrasound probe that automates large field-of-view image acquisition after initial patient positioning.

According to the company, the system incorporates motorized linear translation technology to capture B-mode images over a 10-centimeter scan range. A compliant polyurethane stand-off medium is intended to improve acoustic coupling with irregular anatomical surfaces. The cart-based system also includes a touchscreen interface, integrated battery pack and DICOM-compatible image archival capabilities.

Company executives said the clearance supports broader plans to develop AI-enabled decision-support tools for fracture assessment and musculoskeletal triage.

“FDA clearance of the Accuro XV marks a major inflection point for RIVANNA,” said Will Mauldin, co-founder and chief executive officer of the company. “This clearance demonstrates the scalability of our core platform — shared AI architecture, imaging hardware, and regulatory pathway — across distinct clinical applications. With no targeted point-of-care solution in this space, we are positioned to define the standard of care for extremity injury triage.”

RIVANNA said it is continuing development of several AI-driven software modules for the platform, including BoneEnhance, an image segmentation tool designed to improve bone visualization, and CADe/x, which the company described as the first computer-aided detection algorithm for automated fracture identification derived from volumetric ultrasound imaging.

The company said both technologies are currently being trained and validated through a multi-site clinical study involving eight academic medical centers across the United States.

Delphine Le Roux, senior director of market access and strategic partnerships at RIVANNA, said the company expects the clearance to accelerate development of those AI capabilities.

“The combination of an automated acquisition platform and AI-enabled fracture detection has the potential to democratize access to high-quality musculoskeletal imaging and reduce the burden on imaging resources in high-volume emergency settings,” Le Roux said.

The FDA action follows publication of a feasibility study involving 205 patients that evaluated whether non-physician operators could obtain diagnostic-quality extremity ultrasound images using the system after limited training.

The study, conducted at UVA Health and UT Southwestern Medical Center and published in the Journal of Emergency Medicine, found that more than 90% of scans acquired by both non-physician operators and board-certified emergency physicians were rated adequate for diagnostic interpretation, according to the company. Non-physician users reportedly received one hour of hands-on training before performing scans.

RIVANNA said the Accuro XV is intended to support emergency department workflows by helping clinicians evaluate low-severity extremity injuries at the point of triage and potentially reduce reliance on referrals for conventional X-ray imaging.

The company said future AI-enabled capabilities are intended to support three-dimensional visualization of skeletal structures and assist clinicians in identifying fractures and determining whether patients should be referred for additional radiographic imaging.

RIVANNA said the platform was also designed to support “just-in-time” training aimed at promoting consistent use among healthcare providers with varying levels of clinical experience.