FDA Grants Clearance for BoneEnhance Software Module for Ultrasound Imaging

RIVANNA® has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for BoneEnhance®, a machine learning software module designed for use with the Accuro® XV diagnostic ultrasound system. This innovative module enables bone segmentation and enhances visualization of skeletal anatomy in three-dimensional format during image review.

The clearance transitions the Accuro XV platform from image acquisition to analysis capabilities. Previously cleared in April 2026 for B-mode imaging in musculoskeletal and superficial applications, Accuro XV incorporates a conformable three-dimensional probe that automates large field-of-view image acquisition following initial patient positioning. BoneEnhance represents the first machine learning software module to receive clearance for this platform.

BoneEnhance operates by identifying bone and surrounding tissues within the volumetric dataset created from each automated image acquisition. It applies color-coded overlays on the two-dimensional B-mode images, allowing the original anatomical structures to remain visible beneath the annotations. A three-dimensional indicator next to the image provides guidance on scan orientation and slice location.

This clearance marks a critical advancement for the platform as it integrates decision support starting at the image acquisition stage. While Accuro XV captures the images, BoneEnhance labels the anatomical elements, supported by a comprehensive intellectual property portfolio encompassing over 100 issued and pending patents across more than 20 families.

The effectiveness of BoneEnhance was supported by a nationwide eight-site clinical study. Training data was contributed by three sites, while five additional sites supplied an independent test set comprising 233 volumetric datasets, containing 69,900 images of 173 subjects. Reference labels were established by three board-certified radiologists, and the accuracy of per-volume label prediction ranged from 95.1% to 100.0%.

Furthermore, evidence affirming the platform's automated acquisition capabilities was published in the Journal of Emergency Medicine. In a study involving 205 patients, operators with just one hour of hands-on training successfully acquired wrist and ankle images deemed adequate for diagnostic interpretation in over 90% of cases, achieving image quality comparable to scans performed by physicians.

Looking ahead, RIVANNA is developing an investigational musculoskeletal injury detection module intended to assist clinicians in identifying potential extremity fractures in ultrasound images. The clinical study that validated BoneEnhance is being expanded to include additional sites to enhance the dataset for this new module.

This project has been partly funded by federal resources from the U.S. Department of Health and Human Services, administered by the Biomedical Advanced Research and Development Authority (BARDA) under contract number 75A50121C00035.

The Accuro XV ultrasound system is designed for portable, point-of-care volumetric imaging without ionizing radiation, offering a streamlined approach to musculoskeletal imaging and aiding in emergency department workflows. RIVANNA, headquartered in Charlottesville, Virginia, is a medical technology company focused on delivering AI-driven clinical decision-support solutions powered by proprietary datasets and imaging hardware.