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RIVANNA announces FDA clearance of Accuro 3S Needle Guide Kit
The kit supports infection control and single-operator procedures, enhancing workflow efficiency with sterile, single-use components validated to meet FDA safety standards.
- On Dec. 16, 2025, the U.S. Food and Drug Administration granted 510 clearance for the Accuro 3S Needle Guide Kit, RIVANNA said from Charlottesville, Va.
- The company says the kit supports infection control and streamlines procedures by enabling a single-operator workflow while preserving clinicians' tactile feedback.
- Compatible with the Accuro 3S system, the kit includes single-use sterile consumables, a patient drape with stabilization bands, and an integrated probe cover for secure Dual-Array transducer use.
- Clinicians in spinal procedures may see improved efficiency and infection control in point-of-care spinal needle interventions, potentially altering workflows in musculoskeletal diagnostics.
- Positioning itself as an innovator, RIVANNA develops imaging-based medical technologies and said FDA clearance of the Accuro 3S Needle Guide Kit reflects its commitment to safety and workflow enhancement.
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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…
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