RIVANNA said the FDA has granted 510(k) clearance for the Accuro XV Diagnostic Ultrasound System, authorizing commercial use for musculoskeletal imaging.
The 510(k) clearance comes as RIVANNA accelerates development of AI-enabled capabilities for the Accuro XV platform, including BoneEnhance, an image segmentation module for enhanced bone visualization, and CADe/x, a computer-aided detection algorithm for automated fracture identification derived from volumetric ultrasound imaging. Both capabilities are being trained and validated through an ongoing multi-site clinical study spanning eight academic medical centers nationwide.
"FDA clearance of the Accuro XV marks a major inflection point for RIVANNA," said Will Mauldin, PhD, Co-founder and CEO. "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."
The Accuro XV features a conformable three-dimensional volumetric ultrasound probe that automates large field-of-view image acquisition following initial patient positioning. The system's motorized linear translation technology acquires B-mode images, a 10 cm scan extent; a compliant polyurethane stand-off medium creates a conformable patient contact surface to improve acoustic coupling with irregular anatomies. The cart-based system includes a touchscreen interface, an integrated battery pack for point-of-care mobility, and DICOM-compatible image archival workflows.
