FDA Clears Rivanna BoneEnhance Ultrasound Software

The new module uses machine learning to identify bone structures in volumetric datasets for improved imaging.

Updated on Oct. 22, 2026 in Biotech

Isometric editorial illustration showing a stylized anatomical bone model and ultrasonic wave patterns, representing medical software imaging technology. — The FDA has granted 510(k) clearance to Rivanna for its BoneEnhance software module, which uses machine learning to enhance bone visualization in ultrasound imaging. AI Illustration. Upload story photo >

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The FDA has granted 510(k) clearance to Rivanna for its BoneEnhance software module. The system integrates with the Accuro XV diagnostic ultrasound platform to highlight bone and tissue using color-coded overlays on 2D images.

Why it matters

This clearance validates the use of machine learning in ultrasound imaging to assist clinicians with precise anatomical identification. It marks a significant step for the company as it continues to develop further diagnostic tools for clinical use.

BoneEnhance utilizes machine learning to process 3D probe datasets, achieving 95.1% to 100% label prediction accuracy across 233 datasets from 5 clinical sites. The software maintains anatomical data visibility by layering color-coded highlights over 2D B-mode images.

The players

Rivanna

This is a medical technology company specializing in the development of advanced ultrasound imaging solutions and software.

FDA

The Food and Drug Administration is the federal agency responsible for regulating medical devices and software to ensure they meet safety and efficacy standards.

Biomedical Advanced Research and Development Authority

This federal agency provides funding and support for the development of medical countermeasures and innovative health technologies.

The details

The software is designed to operate specifically with the Accuro XV diagnostic ultrasound system to enhance visualization. Rivanna is also currently leveraging support from the Biomedical Advanced Research and Development Authority to build an investigational module for extremity fracture evaluation.

The FDA officially granted 510(k) clearance for the BoneEnhance software on October 22, 2026.

The Tech Race

The FDA clearance of BoneEnhance follows support provided by the Biomedical Advanced Research and Development Authority. The development of Rivanna's fracture evaluation module follows the pattern of technological advancement supported by this institution.

Clinicians using the Accuro XV system will gain access to automated bone identification, potentially streamlining diagnostic workflows. This integration provides a new digital tool for anatomical visualization without sacrificing the underlying data quality.

The takeaway

This software update reflects the growing reliance on machine learning to assist in real-time diagnostic imaging. Clinicians can expect future tools to continue integrating automated analysis to improve accuracy and speed in clinical assessments.