CHARLOTTESVILLE, VA – MAY 7, 2026 – RIVANNA®, developer of AI-enabled clinical decision-support solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Accuro® XV diagnostic ultrasound system. The clearance marks a pivotal regulatory milestone for RIVANNA, authorizing commercial use of the Accuro XV for musculoskeletal imaging by qualified and trained healthcare professionals in hospital and medical clinic environments.
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, the first 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.