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FDA grants ScanNav Anatomy PNB clearance for sale in the USA

Press releases may be edited for formatting or style | October 21, 2022 Artificial Intelligence Health IT Ultrasound
Intelligent Ultrasound (AIM: IUG), the 'classroom to clinic' ultrasound company, specialising in artificial intelligence (AI) software and simulation announces that the US Food & Drug Administration (FDA) has granted De Novo clearance for clinical use of its AI medical device, ScanNav Anatomy Peripheral Nerve Block (PNB) in the USA. The ScanNav Anatomy PNB product can now be launched into the USA anaesthesiology ultrasound market.

ScanNav Anatomy PNB uses the latest AI technology to assist qualified healthcare professionals to identify and label anatomy in live ultrasound images in preparation for ultrasound guided regional anaesthesia. The real-time anatomy highlighting supports healthcare professionals who perform ultrasound-guided procedures on a less frequent basis by making it easier for them to interpret the ultrasound view of the patient's anatomy.

By classifying ScanNav Anatomy Peripheral Nerve Block (PNB) under its de novo programme, the FDA has concluded that there are no devices already on the market which meet the same clinical need. It has therefore created the new generic type of device classification of real-time anatomy visualization and labelling device for ultrasound guided regional anaesthesia.

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ScanNav Anatomy PNB highlights the anatomy associated with 9 common peripheral nerve blocks and will be sold as a stand-alone device that can be plugged into compatible general-purpose diagnostic ultrasound systems. Users can also re-familiarise themselves with scanning for specific blocks by using the system's integrated 3D animation reference materials.

Ultrasound-guided peripheral nerve block injections are increasingly used for pain relief after surgery and trauma, or as a prudent alternative to general anaesthesia. However, many practitioners do not carry out the procedures regularly, often due to under confidence with ultrasound anatomy. Through the adoption of ScanNav Anatomy PNB, it is hoped that hospitals will be able to increase their delivery of ultrasound-guided nerve blocks.

The Company intends to launch the system to the US market shortly through its existing in-house sales resources based in Alpharetta, Georgia. In addition, the Company continues to seek to license an integrated version of the product to the major ultrasound manufacturers. ScanNav Anatomy PNB is already licensed for clinical use in the UK and Europe. A training simulator is available for medical training on volunteers, prior to patient contact, outside the USA, UK and Europe.

Stuart Gall, CEO of Intelligent Ultrasound Group plc, commented: "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."

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