FDA grants 510(k) clearance for BoneEnhance, the first machine learning layer on RIVANNA's Accuro XV platform
With this clearance, the system can identify different body parts and show bones in three dimensions. A tool to help doctors identify injuries is also being developed for the platform.
CHARLOTTESVILLE, Va., Oct. 22, 2026 /PRNewswire/ -- RIVANNA®, a company that develops AI-powered tools to help doctors make clinical decisions, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for BoneEnhance®. BoneEnhance is a machine learning software module for the Accuro® XV diagnostic ultrasound system. It identifies bones and nearby tissues and helps users view the body's skeletal structure in three dimensions when reviewing images.
This clearance moves the platform beyond capturing images and toward helping users understand them. Accuro XV was cleared in April 2026 to create B-mode ultrasound images for standard muscle and bone imaging and imaging of structures close to the skin's surface. Its flexible three-dimensional probe automatically captures images across a large area after the patient is first positioned. BoneEnhance is the first machine learning software module to receive FDA clearance for this platform.
BoneEnhance identifies bones and nearby tissues
Each automatic scan creates a three-dimensional set of image data for review. BoneEnhance identifies bones and nearby tissues in these data and highlights them with different colors on the two-dimensional B-mode image. The original anatomical information stays unchanged and can still be seen beneath the colored highlights. A three-dimensional guide next to the image shows the scan's direction and where the displayed image slice sits within the full scanned volume.
An important step for the platform
The process follows a clear order: decision-support tools begin working when images are captured. Accuro XV captures the images, and BoneEnhance identifies and labels the body structures shown in them. Supporting this combined process is RIVANNA's worldwide collection of more than 100 granted and pending patents across more than 20 groups of related patents.
"We founded RIVANNA to solve a problem that affects many care settings: information needed for important decisions is often not available as part of the care team's normal workflow," said Will Mauldin, PhD, Co-founder and CEO of RIVANNA. "BoneEnhance begins to close that gap in muscle and bone care. It combines automatic capture of three-dimensional images with software-assisted image review that has now received clearance. This clearance is the starting point: the first machine learning layer supports the decision-making tools we are now developing."
Tested independently in a nationwide study across eight sites
BoneEnhance was trained and tested as part of RIVANNA's nationwide clinical study across eight sites. Three sites supplied data to train the software. The other five sites supplied an independent test set containing 233 three-dimensional scan datasets, made up of 69,900 images from 173 people. None of the test data were used to train or adjust the software. Three radiologists certified by their professional board established the reference labels. The software's accuracy in labeling anatomy across each full scan ranged from 95.1% to 100.0%.
Separate from the testing used to support this clearance, research has also examined the platform's automatic image capture. In a study reviewed by other experts and published in the Journal of Emergency Medicine (DOI: 10.1016/j.jemermed.2025.11.011), 205 patients were studied. Operators who received one hour of practical training captured wrist and ankle images that were judged suitable for diagnostic interpretation in more than 90% of scans. The image quality was comparable to that of scans captured by physicians.
"This clearance shows the strength of the team RIVANNA has built across AI development, clinical affairs, and regulatory work, along with the commitment of the clinical sites that worked with us to produce the evidence," said Delphine Le Roux, PhD, PMP, Senior Director, Market Access and Strategic Partnerships at RIVANNA. "We could not have done this without BARDA's continued support, which helped us follow a careful process with strong evidence from multiple sites and independent testing. The systems, partnerships, and regulatory process we created for BoneEnhance are designed to support future work as well. This ability to carry out the work is what gives us confidence as we pursue our next clearance."
The next software layer is in development
RIVANNA is continuing to develop the platform with an investigational tool to help identify muscle and bone injuries. BoneEnhance labels anatomy, while the new tool is being developed to help clinicians assess possible fractures in the arms and legs using captured ultrasound images. The nationwide clinical study that trained and tested BoneEnhance has grown from eight to ten sites. It is now building the datasets needed to train the new tool. Because the study sites and data systems can be reused for each new module, later modules can build on the program's existing federal investment.
Acknowledgment of federal funding
This project has received full or partial support from federal funds provided by the U.S. Department of Health and Human Services; the Administration for Strategic Preparedness and Response (ASPR); and the Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50121C00035.
About Accuro XV
Accuro XV is a portable three-dimensional ultrasound imaging system with a small footprint. It is designed for use near the patient to capture images of muscles, bones, and related structures. Its flexible three-dimensional probe automatically captures B-mode images across a large area without using ionizing radiation. BoneEnhance is a machine learning software module cleared for use while reviewing three-dimensional scans captured by Accuro XV. It identifies bones and nearby tissues and helps users view the skeletal structure in three dimensions.
A computer-assisted tool to identify muscle and bone injuries is being developed for Accuro XV and has not yet been cleared. It is designed to help clinicians identify fractures in the arms and legs from three-dimensional ultrasound scans and mark signs of injury in soft tissues. It is also intended to support decisions about the next steps in care, including whether the patient should be referred for additional X-ray imaging.
Accuro XV is designed to support fracture care during initial patient assessment. It aims to make emergency department workflows more efficient, speed up the assessment of less severe injuries to the arms and legs, and reduce the need for referrals for X-rays. The platform is designed to support training when needed so that people with different levels of clinical experience can use it consistently. These goals support RIVANNA's wider mission to improve care for muscle and bone injuries and help prepare for emergencies.
About RIVANNA
RIVANNA is a medical technology company that develops tools to help clinicians make decisions. Its products use its own clinical datasets, AI models, and specially designed imaging hardware. The company's platform is designed to automate complex analysis of body structures where care is provided, help clinicians make faster and more confident decisions, reduce differences in results, and make advanced tools available to more people. Its first applications focus on guiding medical procedures and assessing injuries, beginning with procedures involving the area around the spinal cord and assessment of muscle and bone injuries. RIVANNA has a portfolio of products cleared by the FDA and a worldwide collection of more than 100 granted and pending patents. RIVANNA is based in Charlottesville, Virginia, and operates a manufacturing facility registered with the FDA and certified to the ISO 13485:2016 standard.
RIVANNA, Accuro, BoneEnhance, and the Rivanna Medical family of marks are registered and unregistered trademarks of Rivanna Medical, Inc. in the United States and other jurisdictions.
SOURCE RIVANNA
