Rivanna has received U.S. Food and Drug Administration (FDA) 510(k) clearance for BoneEnhance, a machine-learning software module for its Accuro XV diagnostic ultrasound system.
BoneEnhance identifies bone and surrounding tissues within volumetric datasets acquired by the system’s 3D probe and highlights them with color-coded overlays on 2D B-mode images, while leaving the original anatomical data visible, according to the company. In an independent test set of 233 volumetric datasets from five sites, per-volume label prediction accuracy ranged from 95.1% to 100%, Rivanna said.
Rivanna is also developing an investigational module to help clinicians evaluate potential extremity fractures on ultrasound images. The firm said the work has been supported by the U.S. Biomedical Advanced Research and Development Authority.
