RIVANNA announces FDA clearance of Accuro 3S Needle Guide Kit

RIVANNA, developer of world-first imaging-based medical technologies, 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 stabilisation 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.

"The FDA clearance of the Accuro 3S Needle Guide Kit underscores our commitment to providing clinicians with intuitive, workflow-enhancing tools that enhance procedural accuracy and patient safety," said Will Mauldin, PhD, Co-founder and CEO of RIVANNA. "The patient drape's stabilisation bands, which secure the transducer for hands-free positioning, further distinguish our solution in the market by enabling single-operator efficiency and addressing a longstanding ergonomic challenge in real-time neuraxial needle placement."

The Accuro 3S Needle Guide Kit reflects RIVANNA's commitment to advancing ultrasound-guided needle placement through innovative, user-friendly design, with safety and performance confirmed through comprehensive testing in accordance with FDA requirements.