FDA clears Intelligent Ultrasound's AI for real-time guidance in nerve block injections

A new artificial intelligence tool is aiming to improve the delivery of peripheral nerve block (PNB) injections, which may in many surgical cases be a superior option for local anesthesia or pain relief, but which aren’t always used since they require precise placement.

The FDA doled out a de novo clearance to the ScanNav Anatomy PNB device to help guide that placement, its maker, Intelligent Ultrasound, announced Thursday.

With the agency’s blessing, the Welsh company said it will “shortly” begin to market the ScanNav system across the U.S., working through its Georgia-based American sales team. The AI was previously cleared in the U.K. and Europe in spring of 2021; it launched in the U.K. shortly after and is expanding into mainland Europe this month, Intelligent Ultrasound said in a separate Thursday announcement.

ScanNav Anatomy PNB
(Intelligent Ultrasound)

When connected to a diagnostic ultrasound system, the ScanNav technology analyzes scans in real time. It provides side-by-side images of the live ultrasound feed both on its own and with the AI’s annotations, which highlight the specified nerves and all relevant surrounding anatomy and provide tips to improve access to each nerve.

The ScanNav device’s screen can also display 3D models and animations for users’ reference, allowing them to better visualize the most effective approach to a peripheral nerve.

A study published in August found that the AI was able to identify the anatomical structures key to successful nerve block injections in nearly 94% of cases, with false-positive and false-negative rates both clocking in around 3%. Meanwhile, the automated overlays were credited with reducing the risk of nerve block failure in around 81% of the studied ultrasounds and reducing the risk of needle trauma to surrounding anatomy in up to 86% of cases.

The FDA cleared the original version of ScanNav Anatomy PNB, which offers support and real-time guidance for nine common peripheral nerve blocks. But in the second Thursday announcement, Intelligent Ultrasound noted that it has added a tenth PNB program to the system, offering support for femoral nerve blocks—though it didn’t specify which of its markets will have immediate access to all 10 nerve block programs.

The ScanNav Anatomy PNB system is currently sold as a standalone device that simply plugs into healthcare facilities’ compatible general-purpose ultrasound machines, but Intelligent Ultrasound said in Thursday’s FDA announcement that it’s also working on licensing a version of its technology to major ultrasound manufacturers that would integrate the AI into their scanners.

The company took a similar approach with its ScanNav Assist tool, which uses AI to automatically track the collection of ultrasound images during fetal anomaly screening, including making sure that all required views have been recorded and assessing the quality of those images. Intelligent Ultrasound has collaborated with GE Healthcare to integrate AI into ultrasound machines, with ScanNav Assist recently making its way into a second GE scanner thanks to a July deal.