Rivanna’s Accuro XV has secured US Food and Drug Administration (FDA) clearance, setting the stage for the artificial intelligence (AI)-based musculoskeletal imaging system’s commercialisation across hospitals and medical clinics in the US.
Accuro XV uses ultrasound-based bone and 3D soft-tissue imaging technology, along with employing AI-based software to automate the detection and volumetric assessment of skeletal fractures and soft tissue injuries.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Designed for use at the point-of-triage, the system is intended to streamline emergency department workflows, hasten the evaluation of low-severity extremity injuries, and reduce reliance on x-ray referrals, Rivanna stated.
The Virginia-based company’s cart-based system is comprised of a three-dimensional (3D) ultrasound probe for automated large field-of-view image acquisition once a patient is situated.
According to Delphine Le Roux, senior director, market access and strategic partnerships at Rivanna, with FDA clearance in hand, the company is poised to accelerate the development of AI capabilities for Accuro XV to “unlock the system’s full diagnostic potential”.
AI capabilities under development for the system include BoneEnhance, an image segmentation module designed to enhanced bone visualisation, and CADe/x, a computer-aided detection (CAD)-based algorithm for automated fracture identification on the basis of volumetric ultrasound images. These capabilities are currently being trained and validated through Rivanna’s ongoing multi-site clinical study, taking place across eight academic medical centres in the US.
AI is having a significant impact on the healthcare space, with significant application in medical imaging. A report by GlobalData reveals that the combined AI market across healthcare was valued at $11.9bn in 2024 and is expected to reach a valuation of $57.4bn in 2029.
Le Roux continued: “The combination of an automated acquisition platform and AI-enabled fracture detection has the potential to democratise access to high-quality musculoskeletal imaging and reduce the burden on imaging resources in high-volume emergency settings.”
FDA clearance for Accuro XV follows Rivanna’s recent publication of a feasibility study of the system. Conducted at UVA Health and UT Southwestern Medical Center and published in the Journal of Emergency Medicine, the study enrolled 205 patients and found that more than 90% of scans in both operator groups were rated adequate for diagnostic interpretation.
Commenting on the FDA clearance, Rivanna’s CEO, Will Mauldin, said: “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.”
