FDA Clears BoneEnhance Software for Ultrasound Imaging
The machine-learning module adds color-coded bone overlays to 2D ultrasound images for use with the Accuro XV system.
Updated on Oct. 22, 2026 in Biotech
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Rivanna has received FDA 510(k) clearance for its BoneEnhance software module, which uses machine learning to identify bone and tissue. The system is designed to operate with the company's Accuro XV diagnostic ultrasound hardware.
Why it matters
This clearance validates the use of automated volumetric analysis in standard ultrasound workflows. It further enables Rivanna to expand its clinical utility, specifically regarding an ongoing research project for fracture assessment.
BoneEnhance utilizes machine learning algorithms to process 3D volumetric datasets. In independent testing across 233 datasets, the software achieved a per-volume label prediction accuracy of 95.1% to 100%.
The players
Rivanna
A developer of diagnostic ultrasound technology that integrates automated volumetric analysis and machine learning to assist in anatomical imaging.
Biomedical Advanced Research and Development Authority
A federal agency under the U.S. Department of Health and Human Services that funds and supports medical countermeasures for public health threats.
The details
The software identifies anatomical structures within volumetric datasets and renders them as color-coded overlays on 2D B-mode ultrasound images. B-mode—or brightness mode—ultrasound provides a standard 2D view of internal tissues by measuring the intensity of reflected sound waves. This approach maintains the visibility of the original anatomical data while providing a high-contrast visual cue for bone detection, ensuring clinicians retain access to the source imaging for validation.
Timeline
October 22, 2026: The FDA officially granted 510(k) clearance for the BoneEnhance software.
The Tech Race
This clearance represents a regulatory milestone for integrating AI-based bone detection into portable ultrasound hardware. The company is now building on this foundation with support from the Biomedical Advanced Research and Development Authority to develop an investigational fracture assessment tool.
Clinicians using the Accuro XV diagnostic ultrasound system will gain access to BoneEnhance overlays once the company initiates its rollout. The software adds a machine-learning-driven interpretation layer to existing 2D B-mode images, aimed at streamlining bone and tissue identification.
The takeaway
The FDA clearance marks the first commercial step for this machine learning tool in ultrasound workflows. Watch for future performance data related to the investigational module for extremity fracture evaluation currently in development.
Further reading
Explore the latest developments in medical diagnostics and regulatory approvals in the Biotech section.
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