Musculoskeletal ultrasound system nabs FDA clearance

A new point-of-care ultrasound system for bedside musculoskeletal examinations has been cleared by the U.S. Food and Drug Administration. 

Artificial intelligence solutions and medical technology company Rivanna, which is based in Charlottesville, Virginia, last week announced the clearance of its Accuro XV Diagnostic Ultrasound System. The system comes equipped with a conformable 3D volumetric ultrasound probe that automates a large field-of-view B-mode image acquisitions based on patient positioning. This setup was designed with novice users in mind so that imaging can be completed quickly at the bedside, expediting diagnosis and treatment in urgent and emergency care. 

The system also will be integrated with AI-enabled applications once they have been cleared by the FDA. These include BoneEnhance, a machine learning software that segments musculoskeletal anatomy to provide detailed 3D visualization of skeletal structures, and a CADe/x module that also uses machine learning to assist clinicians in spotting fractures and making additional triage decisions, including referral for additional imaging. These modules are currently being trained and validated across eight academic medical centers throughout the U.S. 

"FDA clearance of the Accuro XV marks a major inflection point for Rivanna," Will Mauldin, PhD, co-founder and CEO, said in a news release. "This clearance demonstrates the scalability of our core platform—shared AI architecture, imaging hardware, and regulatory pathway—across distinct clinical applications."

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