Intelligent Ultrasound’s ScanNav Gains De Novo Clearance for Ultrasound Guided Anesthesiology

Intelligent Ultrasound has received De Novo clearance from the FDA for its ScanNav anatomy peripheral nerve block, an artificial intelligence-based tool for identifying and labeling anatomical structures for ultrasound-guided regional anesthesia.

The device, which highlights the anatomy associated with nine common peripheral nerve blocks, will be sold as a stand-alone unit that can be plugged into compatible diagnostic ultrasound systems.

The FDA grants the De Novo classification to devices for which there are no comparable products already on the market that meet the same clinical need.