Rivanna has received FDA 510(k) clearance for its Accuro XV Diagnostic Ultrasound System. The clearance authorizes commercial use for musculoskeletal imaging by qualified and trained healthcare professionals in hospital and medical clinic settings.
Accuro XV is a portable, small-footprint point-of-care volumetric ultrasound system for musculoskeletal imaging, according to the company. Rivanna said the system automates large field-of-view B-mode image acquisition without ionizing radiation.
A conformable 3D volumetric ultrasound probe is used after initial patient positioning. Motorized linear translation technology acquires B-mode images across a 10-cm scan extent, while a polyurethane stand-off medium is intended to improve acoustic coupling over irregular anatomy.
DICOM-compatible image archival workflows are included in the cart-based system. Rivanna said the system also has a touchscreen interface and integrated battery pack for point-of-care mobility.
AI-enabled capabilities for the platform remain in development. These include BoneEnhance, an image segmentation module for bone visualization, and CADe/x, a computer-aided detection algorithm for automated fracture identification from volumetric ultrasound imaging.
Both software capabilities are being trained and validated through an ongoing multisite clinical study spanning 8 academic medical centers nationwide, Rivanna said.
That study was expanded in April from 2 to 8 sites after the Biomedical Advanced Research and Development Authority executed a funding option, according to the company. Participating sites include Denver Health, Texas Tech Health El Paso, UCSF, the University of Utah, UVA Health, UT Southwestern Medical Center, Virginia Commonwealth University, and Yale University.
Rivanna also cited a 205-patient feasibility study conducted at UVA Health and UT Southwestern Medical Center. The company said more than 90% of scans acquired by both non-physician operators and board-certified emergency physicians were rated adequate for diagnostic interpretation.
Company:Rivanna
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