Intelligent Ultrasound, a company that develops software aimed at improving the quality, reliability and diagnostic power of medical ultrasounds, recently received de novo clearance from the US Food and Drug Administration (FDA) for its ScanNav Anatomy PNB (peripheral nerve block) device.

ScanNav Anatomy PNB is an artificial intelligence (AI) powered medical device and system intended to be used during regional anaesthesia procedures. The device is designed to help healthcare professionals perform ultrasound-guided PNB and works by highlighting the live ultrasound image to help identify the key anatomical structures while performing peripheral nerve block procedures. ScanNav Anatomy PNB is designed to enhance the accuracy of ultrasound imaging through a colour overlay of key sono-anatomical structures during a live ultrasound.

This device could be a game-changer for PNB. With the AI assistant highlighting anatomical structures via ultrasound, PNB accuracy and ultimately safety could improve greatly. ScanNav Anatomy PNB uses AI technology and will provide a scan assessment of anatomical structures in the body by identifying and grading ultrasound images with deep-learning technology.

ScanNav Anatomy PNB supports the following nine popular ultrasound-guided regional anaesthesia procedures: Interscalene, Superior Trunk, Supraclavicular, Axillary, Erector Spinae Plane, Rectus Sheath, Suprainguinal Fascia Iliaca, Adductor Canal/Sub-sartorial femoral triangle, and Popliteal. Additionally, the device is compatible with general-purpose ultrasound machines with HDMI or DVI second monitor ports.

Since the FDA has classified ScanNav Anatomy PNB under its de novo programme, the agency has concluded that there are no devices already on the market that meet the clinical need, leading to the creation of the new generic type of device classification for real-time anatomy visualisation and labelling device for ultrasound-guided regional anaesthesia.