RIVANNA has received U.S. FDA 510(k) clearance for its Accuro® XV Diagnostic Ultrasound System, allowing the company to commercially offer the device for musculoskeletal imaging in hospitals and medical clinics.
The clearance represents an important regulatory milestone and supports the expansion of the company’s AI-enabled imaging portfolio.
The Accuro XV is designed to assist healthcare professionals with musculoskeletal assessments using a three-dimensional volumetric ultrasound probe.
The system automates large field-of-view image acquisition and features motorised linear translation technology to capture high-quality B-mode images. It also includes a touchscreen interface, an integrated battery pack for mobility and DICOM-compatible image storage capabilities.
These technologies are currently being evaluated through a multi-site clinical study involving eight academic medical centres across the United States.
The FDA clearance follows the publication of a feasibility study conducted at UVA Health and UT Southwestern Medical Centre.
The study involved 205 patients and demonstrated that non-physician operators could obtain diagnostic-quality extremity images after only one hour of practical training.
More than 90% of scans from both non-physician operators and emergency physicians were considered suitable for diagnostic interpretation.
The company believes the platform could help expand access to musculoskeletal imaging and support faster injury assessment in busy clinical settings.
