Rivanna has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Accuro 3S diagnostic ultrasound system and SpineNav-AI image processing software.

The portable, point-of-care Accuro 3S ultrasound features a proprietary Dual-Array convex probe with the integrated SpineNav-AI software. The probe consists of two aligned transducer arrays arranged side-by-side with a narrow gap, which allows an in-line needle approach through the probe’s center.

Images from both arrays are combined to optimize visualization of the anatomy. The platform supports standard B-mode imaging and has a touchscreen interface, maneuverable cart-based design, and connectivity to implement DICOM-based patient and image archival workflows.

The SpineNav-AI machine learning-based software facilitates musculoskeletal assessments of the lumbar spine to support real-time visualization during anesthesia procedures. It automatically detects landmarks and identifies critical spinal anatomy, which can help standardize spinal image interpretation, the company said.

The software leverages an artificial intelligence (AI)-based image processing architecture to identify key anatomical structures in ultrasound images and indicate the position of the spine midline. When the software detects the epidural space, it indicates its position and measurement.

The company said the next steps are to pursue further regulatory submissions for additional advanced Accuro 3S capabilities. Clinical collaborations are underway, with an impending limited release of Accuro 3S to select academic medical centers. A broader market launch will follow.

“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,” RIVANNA co-founder and CEO Will Mauldin, Ph.D. told the press. “Our solution addresses these technical barriers, making ultrasound guidance more accessible and supporting enhanced safety, precision, and patient care.”