Intelligent Ultrasound has received the US Food & Drug Administration (FDA) De Novo approval for clinical use of its ScanNav Anatomy Peripheral Nerve Block (PNB) device.

With the FDA De Novo approval, the UK-based ultrasound company can commercialise its AI-based medical device in the US anaesthesiology ultrasound market.

ScanNav Anatomy PNB leverages advanced AI technology to help healthcare professionals identify and label anatomy in live ultrasound images for guided regional anaesthesia.

Its real-time anatomy highlighting feature will make it easier for healthcare professionals to interpret the ultrasound view of the patient’s anatomy, said Intelligent Ultrasound.

Intelligent Ultrasound Group CEO Stuart Gall said: “We’re delighted to have received the FDA De Novo grant for our second AI product and to build on the success of ScanNav Assist, our obstetric AI software.

“ScanNav Anatomy PNB will launch into the US anaesthesiology ultrasound market, continuing the expansion of our AI-based real-time clinical ultrasound image analysis software.

“Although all new medical markets take time to develop, we are excited about the long-term potential of our increasing range of AI image analysis products.”

According to the company, ultrasound-guided peripheral nerve block injections are used for pain relief after surgery and trauma, or as an alternative to general anaesthesia.

Intelligent Ultrasound said that its ScanNav Anatomy PNB has been designed to deploy AI algorithms to highlight the anatomy related to nine common peripheral nerve blocks.

Its 3D reference material provides an overview of the relevant anatomy, and probe positioning and facilitates virtual scanning for the selected anatomical region.

The company said that the adoption of ScanNav Anatomy PNB will enable hospitals to increase their delivery of ultrasound-guided nerve blocks.

It intends to launch the system to the US market as a stand-alone device that can be plugged into compatible general-purpose diagnostic ultrasound systems.

Furthermore, ScanNav Anatomy PNB is already licensed in the UK and Europe and comes with a training simulator for training medical volunteers outside the US, the UK, and Europe.