Last Updated on December 31, 2023 by The Health Master
The United State Food and Drugs Administration (USFDA) doled out a de novo clearance to the ScanNav Anatomy PNB device to help guide that placement, its maker, Intelligent Ultrasound, announced Thursday.
This new artificial intelligence tool aims 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.
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 the 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.
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.
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.
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