FDA Clears Point-Of-Care Ultrasound Platform and AI Software for Neuraxial Procedures

The Food and Drug Administration (FDA) has granted separate 510(k) clearances for the Accuro 3S point-of-care ultrasound system and SpineNav-AI machine learning software, modalities designed to overcome traditional challenges with ultrasound-guided neuraxial procedures.

The portable Accuro 3S ultrasound features a proprietary Dual Array convex probe with transducer arrays that facilitate optimal visualization and a narrow gap between the aligned arrays that allows an in-line needle approach, according to Rivanna, the manufacturer of the ultrasound platform.

Rivanna noted that SpineNav-AI offers automated detection of landmarks and identification of critical spine anatomy to assist with spinal image interpretation, as well as the epidural space position.

“Historically, ultrasound-guided neuraxial procedures have been limited by the need to simultaneously handle the needle, probe, and syringe, as well as by steep needle angles that restrict visualization, and difficulty maintaining a real-time in-plane approach with conventional probes. Our solution addresses these technical barriers, making ultrasound guidance more accessible and supporting enhanced safety, precision, and patient care,” noted Will Mauldin, Ph.D., the co-founder and CEO of Rivanna.