RIVANNA announces FDA clearance of Accuro 3S Needle Guide Kit
CHARLOTTESVILLE, Va., Dec. 16, 2025 /PRNewswire/ — RIVANNA®, developer of world-first imaging-based medical technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Accuro® 3S Needle Guide Kit consumables. This clearance marks a significant milestone in advancing the safety and effectiveness of ultrasound-guided needle placement.
The Accuro 3S Needle Guide Kit, designed for use with the Accuro 3S ultrasound imaging system and Dual-Array™ transducer, includes single-use, sterile components that support infection control and promote workflow efficiency. The sterile patient drape is equipped with stabilization bands that secure the transducer for hands-free support during needle approach, facilitating a streamlined, single-operator workflow. This configuration allows clinicians to maintain both hands on the needle for tactile feedback. The Dual-Array transducer supports midline placement through the probe’s central aperture, while the integrated probe cover isolates the needle insertion site from contaminants to help maintain a controlled procedural field.
