Accuro XV Musculoskeletal Ultrasound Device Garners FDA Clearance

The Food and Drug Administration (FDA) has granted 510(k) clearance for the Accuro XV musculoskeletal ultrasound system, which may facilitate improved access and triage for musculoskeletal imaging.

In addition to facilitating DICOM-compatible image archive workflows, the cart-based Accuro XV system provides a touchscreen interface, an integrated battery pack for point-of-care mobility and a three-dimensional (3D) probe that enables automated acquisition of large field-of-view images, according to Rivanna, the developer of the Accuro XV system.¹

In a recent 205-patient study, published in the Journal of Emergency Medicine, researchers found that non-physician operators, after an hour of training, were able to obtain diagnostically adequate images with the Accuro XV system at a greater than 90 percent rate, which was similar to that of board-certified emergency physicians.²

"FDA clearance of the Accuro XV marks a major inflection point for Rivanna," said Will Mauldin, PhD, the co-founder and CEO of Rivanna. "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."

Rivanna is currently studying an AI segmentation model to bolster bone visualization (BoneEnhance) and an algorithm for automated fracture identification (CADe/x) that could be added to the Accuro XV platform in the future, according to the company.¹

References

1. Rivanna. Rivanna receives FDA 510(k) clearance for Accuro XV musculoskeletal ultrasound imaging system. PR Newswire. Available at: https://www.prnewswire.com/news-releases/rivanna-receives-fda-510k-clearance-for-accuro-xv-musculoskeletal-ultrasound-imaging-system-302766062.html . Published May 7, 2026. Accessed May 8, 2026.

2. Thom C, Vietvuong V, Ottenhoff J, et al. Comparison of ultrasound image quality between users on a novel automated device for extremity injury. J Emerg Med. 2026 Feb:81:9-18. doi: 10.1016/j.jemermed.2025.11.011 .