Rivanna Medical has received 510 (k) approval from the US Food and Drug Administration (FDA) for its Accuro 3S diagnostic ultrasound system and SpineNav-AI image processing software.
The approval enables the use of ultrasound technology in US hospitals and clinical settings, providing anatomical guidance during needle or catheter placement procedures.
The Accuro 3S is a portable, point-of-care ultrasound system featuring a Dual-Array convex probe and integrated SpineNav-AI software.
Its dual-array probe comprises two aligned transducer arrays with a narrow gap, allowing an in-line needle approach through the probe’s centre.
The combined images from both arrays optimise anatomical visualisation, supporting standard B-mode imaging.
The system is equipped with a touchscreen interface, a manoeuvrable cart-based form factor, and healthcare IT connectivity for DICOM-based patient and image archival.
Rivanna Medical co-founder and CEO Will Mauldin said: “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.
“We are excited to introduce this next-generation platform to the market and continue advancing innovation in image-guided anaesthesia procedures. This innovation tackles longstanding challenges in procedural guidance.”
SpineNav-AI is a machine learning-based software solution that aids musculoskeletal imaging assessments of the lumbar spine, supporting real-time visualisation during anaesthesia procedures.
It automates landmark detection and identifies critical spinal anatomy, assisting clinicians by standardising the interpretation of spinal images.
The software’s AI-based image processing architecture identifies key anatomical structures in ultrasound images and indicates the position of the spine midline. When detected, the position and depth of the epidural space are also indicated.
The Accuro 3S platform enhances imaging capabilities and integrates software tools to support accuracy and efficiency in neuraxial anaesthesia procedures.
It includes consumables such as a Probe Cover Needle Guide Kit, designed to stabilise probe positioning and facilitate needle alignment.
The system enables clinicians to locate the epidural space, assess its depth, and insert the needle under live visualisation.
Furthermore, the US-based medical device maker is planning to pursue additional regulatory submissions for further advanced capabilities of the Accuro 3S.
Mauldin added: “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 visualisation, 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.”
