Intelligent Ultrasound Group said its ScanNav Anatomy Peripheral Nerve Block (PNB) device has been granted de novo clearance for clinical use by the U.S. Food and Drug Administration (FDA).
ScanNav helps users identify and label anatomy in live ultrasound images in preparation for ultrasound-guided regional anesthesia. It highlights the anatomy associated with nine common peripheral nerve blocks and will be sold as a standalone product that can be used with compatible ultrasound systems, the company said.
Intelligent Ultrasound said it plans to license ScanNav to ultrasound manufacturers and is making a training simulator available for volunteers outside the U.S., the U.K., and Europe.
