FDA Clears Intelligent Ultrasound’s ScanNav Peripheral Nerve Block Device

Intelligent Ultrasound (IU) has received U.S. Food and Drug Administration de novo clearance for clinical use of its ScanNav Anatomy PNB. The company intends to launch the system to the U.S. market through its existing in-house sales resources based in Alpharetta, Ga.

IU has also added more functionality to the ScanNav Anatomy Peripheral Nerve Block (PNB) platform and widened its availability to support regional anesthesia in mainland Europe and the United States.
 
Designed to help qualified healthcare professionals perform ultrasound-guided regional anesthesia safely, ScanNav Anatomy PNB enhances the accuracy and standardization of ultrasound image interpretation. Developed with anesthesiology experts, ScanNav Anatomy PNB uses next-generation artificial intelligence (AI) algorithms to highlight structures relevant to regional anesthesia during a live ultrasound scan. 3D reference material provides an overview of the relevant anatomy, probe positioning and demonstrates virtual scanning for the selected anatomical region.
 
First launched into market in 2021, IU is now launching the solution into new countries. With the addition of the new femoral block, ScanNav Anatomy PNB supports anatomy highlighting for 10* vital regions relevant to ultrasound-guided regional anesthesia, including all seven ‘Plan A’ blocks endorsed by RA-UK [Turbitt et al., 2020].
 
Recent publications, including one published by the British Journal of Anaesthesia in August 2022, support the growth in interest around the use of AI for ultrasound image interpretation in regional anesthesia and the platform, showing that “Highlighting by ScanNav in this study was perceived to reduce block failure in 81.2% of scans (according to subjective expert opinion).”
 
ScanNav Anatomy PNB is a licensed medical device in the United Kingdom and Europe. 
 
* The number of regions may vary between jurisdictions.