Rivanna’s AI-Enhanced Musculoskeletal Ultrasound Earns FDA OK

RIVANNA, maker of artificial intelligence (AI)-enabled clinical decision support solutions, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Accuro XV diagnostic ultrasound system for musculoskeletal imaging.

Accuro XV boasts AI-enabled capabilities such as BoneEnhance, an image segmentation module for enhanced bone visualization, and CADe/x, a computer-aided detection algorithm for automated identification of fractures derived from volumetric ultrasound imaging. Both functions are being trained and assessed through a current multi-site clinical study taking place in eight academic medical centers in the U.S.

The device has a conformable, 3D volumetric probe that automates large field-of-view acquisition after initial positioning of the patient. Its motorized linear translation tech acquires B-mode images, a 10 cm scan extent, and a compliant polyurethane stand-off medium that make a conformable patient contact surface to boost acoustic coupling with irregular anatomies.

The system is cart-based and has a touchscreen interface, integrated battery pack, and DICOM-compatible image archival.

“FDA clearance of the Accuro XV marks a major inflection point for RIVANNA,” said Will Mauldin, Ph.D., RIVANNA’s 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 ultrasound’s clearance comes after recent publication of a feasibility study showing non-physician operators could acquire diagnostic-quality extremity images after an hour of hands-on training, with image quality comparable to board-certified emergency physicians. 90% of scans in both operator groups were rated adequate for diagnostic interpretation.

“With FDA clearance in hand, we can accelerate building the AI capabilities that will unlock the system’s full diagnostic potential,” said Delphine Le Roux, Ph.D., PMP, senior director, Market Access and Strategic Partnerships at RIVANNA. “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.”

In July 2025, the company secured FDA clearance for its next-gen Accuro 3S diagnostic ultrasound system and SpineNav-AI image processing software to guide spinal anesthesia.