Rivanna has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for its Accuro XV Diagnostic Ultrasound System.
The platform features a three-dimensional volumetric ultrasound probe that automates large field-of-view image acquisition following initial patient positioning, according to the firm. The system’s design creates a conformable patient contact surface to improve acoustic coupling with irregular anatomies, the company said, also noting DICOM-compatible image archival workflows.
Rivanna also highlighted the platform’s AI-enabled capabilities. They include BoneEnhance, an image segmentation module, and a computer-aided detection algorithm for automated fracture identification derived from volumetric ultrasound imaging. The software is being trained and validated through an ongoing multisite clinical study spanning eight academic medical centers nationwide, the company said.