RIVANNA Achieves FDA Clearance for Ultrasound Guidance and AI Imaging Solutions

RIVANNA Achieves FDA Clearance for Innovative Medical Technologies

RIVANNA, the pioneer in imaging-based medical technologies, has recently announced a significant achievement in the field of medical imaging. The company secured the 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking Accuro® 3S diagnostic ultrasound system and SpineNav-AI™ image processing software. This regulatory milestone is a substantial advancement for RIVANNA, as it allows both technologies to be utilized in hospitals and clinical settings across the United States.

The Next Generation of Ultrasound Guidance

The Accuro 3S is an innovative, portable ultrasound device designed for point-of-care applications. It is equipped with a state-of-the-art Dual-Array™ convex probe, which houses two aligned transducer arrays that work in tandem, offering better anatomical visualization. This allows for a streamlined approach to needle or catheter placement, an essential facet of many medical procedures. The system also boasts a user-friendly touchscreen interface and is designed to integrate seamlessly with healthcare IT systems, facilitating compliance with DICOM protocols for patient and image archival.

What sets Accuro 3S apart is its combination of standard B-mode imaging capabilities with advanced features enabled by the integrated SpineNav-AI software. This machine learning-based software enhances the accuracy of musculoskeletal imaging assessments, specifically targeting the lumbar spine. By providing real-time visualization during anesthesia procedures, the software significantly improves the standardization of spinal image interpretation.

Revolutionizing Spinal Procedures

Dr. Will Mauldin, Co-founder and CEO of RIVANNA, highlighted the profound impact of this achievement, stating, “Achieving 510(k) clearance for Accuro 3S and SpineNav-AI ahead of schedule marks a significant milestone for RIVANNA and demonstrates the strength of our engineering and clinical partnerships.” He expressed excitement about bringing these next-generation solutions to the market, aiming to advance the field of image-guided anesthesia procedures.

Traditionally, conducting ultrasound-guided neuraxial procedures has presented numerous challenges. Clinicians often face difficulties managing a needle, probe, and syringe simultaneously while trying to maintain an optimal angle for visualization. RIVANNA's solutions are designed to surmount these hurdles, offering enhanced safety and precision during procedures, ultimately improving patient care.

Enhancements for Improved Precision

The Accuro 3S platform further builds on RIVANNA's proven track record of improving success rates in spinal interventions. It offers advanced imaging capabilities complemented by integrated software tools, which aim to augment precision and efficiency in neuraxial anesthesia. One notable component is the consumable Probe Cover Needle Guide Kit, designed to stabilize probe positioning and assist in aligning the needle effectively. This enhancement aims to assist clinicians in accurately identifying the epidural space and measuring its depth with the aid of live imaging.

Future Directions

Looking ahead, RIVANNA plans to pursue additional regulatory submissions to expand the capabilities of the Accuro 3S platform further. Continuing its commitment to innovation, the company has initiated collaborations with clinical partners, gearing up for an exclusive limited release of the Accuro 3S at selected leading academic medical centers. This will precede a wider market launch, allowing even more practitioners to utilize this cutting-edge technology to aid in spinal care.

About RIVANNA

RIVANNA is a commercial-stage medical device innovator based in Charlottesville, VA, specializing in pioneering imaging-based technologies that aim to set new standards in patient care. The company's commitment to developing comprehensive solutions for point-of-care spinal needle interventions and musculoskeletal diagnostics underscores its position as a leader in medical technology advancement. For more information about RIVANNA and its offerings, visit their official website.