Rivanna receives FDA clearance for Accuro XV ultrasound

Rivanna has received U.S. Food and Drug Administration 510(k) clearance for its Accuro XV Diagnostic Ultrasound System, authorizing commercial use for musculoskeletal imaging.

The Charlottesville, VA-based company said the system is intended for use by qualified and trained healthcare professionals in hospitals and medical clinics. The clearance allows Rivanna to market Accuro XV for musculoskeletal imaging, including potential point-of-care use in extremity injury assessment.

Accuro XV uses a 3D volumetric ultrasound probe designed to automate large field-of-view image acquisition after initial patient positioning. The system uses motorized linear translation technology to acquire B-mode images across a 10-cm scan extent, according to Rivanna.

The device also includes a conformable patient contact surface intended to improve acoustic coupling over irregular anatomy. That design feature could matter in musculoskeletal imaging, where extremity surfaces and injury sites may be difficult to scan consistently with conventional handheld ultrasound probes.

Rivanna said the system includes DICOM-compatible image archival workflows. For imaging departments and clinics, that means Accuro XV data can be incorporated into existing medical imaging infrastructure rather than remaining isolated at the point of care.

The clearance comes as the company continues development of AI-enabled capabilities for the platform. These include BoneEnhance, an image segmentation module for enhanced bone visualization, and CADe/x, a computer-aided detection algorithm for automated fracture identification from volumetric ultrasound imaging.

Both AI capabilities are being trained and validated through an ongoing multisite clinical study spanning 8 academic medical centers nationwide, according to Rivanna. The software is still described as advancing toward FDA clearance, meaning the current clearance applies to the Accuro XV diagnostic ultrasound system itself, not necessarily to all future AI decision-support features.

“FDA clearance of the Accuro XV marks a major inflection point for RIVANNA,” said Will Mauldin, PhD, cofounder and CEO.

Mauldin said the clearance demonstrates the scalability of Rivanna’s shared AI architecture, imaging hardware, and regulatory pathway across clinical applications. The company is positioning the platform for extremity injury triage, where fracture assessment usually depends on radiography, CT, or follow-up imaging when initial findings are uncertain.

For radiology and emergency-care workflows, the potential value will depend on how well volumetric ultrasound can fit into existing fracture triage pathways. If the AI modules are eventually cleared and validated clinically, the platform could offer an additional imaging option for musculoskeletal assessment, especially in settings seeking rapid point-of-care evaluation.

The next milestone will be evidence. Rivanna’s ongoing multicenter validation work will need to show whether automated volumetric ultrasound and AI-assisted fracture detection can deliver reliable performance across anatomical sites, operators, and clinical settings.