Intelligent Ultrasound receives CE approval for ScanNav PNB
(IUG ) unveiled that it has received CE mark approval for its second artificial intelligence product, ScanNav Anatomy: Peripheral Nerve Block ("ScanNav PNB").
ScanNav highlights live ultrasound images to enhance the accuracy and standardisation of ultrasound image interpretation, by making it easier to identify key anatomical structures.
The technology aims to support the performance of healthcare professionals who are suitably qualified but who perform ultrasound-guided procedures on a less frequent basis. ScanBav PNB supports nine common peripheral nerve blocks, a form of local anaesthesia.
Increasingly, it seems ultrasound-guided peripheral nerve blocks are being used as a prudent alternative to general anaesthesia. However, not all anaesthetists have the specialist knowledge of ultrasound anatomy to perform them, the Company outlined.
Through the adoption of ScanNav PNB, the Company said it is hoped that hospitals will be able to increase the number of ultrasound-guided nerve blocks that they can perform.
The product will be sold as a stand-alone device, with in-built AI software, that can be plugged into existing anaesthesiology ultrasound machines while the device will provide clinicians with continuous feedback from real-time highlighting of their live ultrasound.
The Company highlighted that users can also re-familiarise themselves with blocks that are carried out less frequently using the system's integrated 3D animations. ScanNav PNB is also available as a training simulator for medical learning on volunteers, prior to patient contact.
The Company said it intends to sell the stand-alone system to the UK market through its existing in-house sales resources, with an expected launch in Q2 2021.
In addition, the Company also continues to progress the product's FDA regulatory filing to enable a version of the product to be sold in the US, as well as seeking to licence an integrated version of the product to the major ultrasound manufacturers.
Commenting on the approved product, Lead clinician and consultant anaesthetist, Dr David Burckett-St.Laurent, said, "ScanNav PNB will help tip the balance of safety and confidence in favour of performing regional anaesthesia. I feel privileged to have been working with a company that is leading the world in developing AI-based ultrasound software.”
He added, “Our aim has been to make a real clinical difference to patients by increasing the availability of regional anaesthesia through cutting edge technology. It is very exciting that the product has now moved out of the lab and into clinical practice."
Stuart Gall, Intelligent Ultrasound’s CEO said, "Building on the success of ScanNav Assist, our first obstetric AI software that is integrated into GE Healthcare's recently launched SWIFT ultrasound machine, ScanNav Anatomy PNB will launch into the anaesthesiology ultrasound market and continues the Group's expansion into AI-based real-time clinical ultrasound image analysis.
We are particularly pleased that many of the independent clinicians who used ScanNav PNB during product testing think that it would benefit them in their everyday clinical practice."
Today’s news marks the Group’s second artificial intelligence product to be CE-marked as it continues its expansion into AI-based real-time clinical ultrasound image analysis.
Shares in Intelligent Ultrasound have now recovered strongly from lows of 10p at the height of the COVID crisis with the stock gaining over 30% since the beginning of March 2021 alone. The stock was trading 6.62% higher this morning at 18.92p following the announcement.
Intelligent Ultrasound develops AI-based clinical image analysis software tools for the diagnostic medical ultrasound market and hi-fidelity VR simulators for the ultrasound training and education markets.
Recent Positive News
In a recent trading update for the 12 months to December 2020, IUG said it has enough operational flexibility to weather the COIVID storm, whilst investing for future growth.
Sales from its direct UK and US sales team are expected to have grown by over 15% to £3.8m (FY19: £3.3m), helped by strong sales from the Group's ScanTrainer and BodyWorks simulators, which incorporate the group’s ‘free of charge’ Covid-19 lung training module.
However, sales in Europe and Asia, that are made through IUG’s reseller network, were impacted by Covid-19 restrictions and are expected to have declined to £1.4m (FY19: £2.6m).
Global Partnership with GE
The Group announced in 2020 that it had been working closely with GE to commercialise its AI technology. GE launched the “Voluson SWIFT” ultrasound machine in October 2020, that incorporates IUG’s ScanNav Assist AI technology in its SonoLyst software. GE now has both CE approval for sale in Europe and 510(k) clearance from the FDA for sale in the USA.
GE’s SonoLyst is the first AI software to be launched under IUG’s long-term licence and co-development agreement with GE. It is also the world's first fully integrated AI tool that recognises the 20 views recommended by the International Society of Ultrasound in Obstetrics and Gynaecology mid-trimester practice guidelines for fetal imaging. The Voluson SWIFT is the first of the three product types in GE’s Voluson range to offer SonoLyst.
The GE Voluson SWIFT, when deployed in private healthcare settings, increases the speed of ultrasound procedures whilst ensuring correct quality levels are consistently achieved.
This has the potential to increase revenue for the operator and therefore provide GE Healthcare with a more compelling sales proposition than that of its competitors.
Prof Aris Papageorghiou, Professor of Fetal Medicine, St George's Healthcare NHS Trust, London called the technology a “big advance for ultrasound imaging in women’s health.”
He added, “I have worked in the field of AI in ultrasound for over ten years, yet I am still amazed at the level of accuracy that has been achieved. You can really see how Intelligent Ultrasound's AI technology, incorporated in the SonoLyst software, will improve efficiency, make the learning of ultrasound easier and reduce omissions and errors.”
Commenting on the trading update, Stuart Gall, CEO of Intelligent Ultrasound Group said the group had seen “a very positive year” despite the impact of Covid-19, commenting:
“The Clinical AI Division has continued to perform well, with GE Healthcare's Voluson SWIFT ultrasound machine, that incorporates Intelligent Ultrasound's ScanNav Assist AI technology in its SonoLyst software, receiving CE approval for sale in Europe and 510(k) clearance from the FDA for sale in the USA.”
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