Intelligent Ultrasnd - ScanNav Anatomy PNB clearance for sale in the USA
20/10/2022 07:00
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RNS Number : 4735D Intelligent Ultrasound Group PLC 20 October 2022
20 October 2022
Intelligent Ultrasound Group plc
(the "Group" or the "Company" or "Intelligent Ultrasound")
FDA grants ScanNav Anatomy PNB clearance for sale in the USA
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.
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."
Enquiries:
Intelligent Ultrasound Group plc www.intelligentultrasound.com (http://www.intelligentultrasound.com)
Stuart Gall, CEO Tel: +44 (0)29 2075 6534
Helen Jones, CFO
Cenkos Securities Tel: +44 (0)20 7397 8900
Giles Balleny / Max Gould (Corporate Finance)
Dale Bellis / Julian Morse (Sales)
Walbrook PR Tel: +44 (0)20 7933 8780 or intelligentultrasound@walbrookpr.com
(mailto:intelligentultrasound@walbrookpr.com)
Anna Dunphy Mob: +44 (0)7876 741 001
About Intelligent Ultrasound Group
Intelligent Ultrasound (AIM: IUG) is one of the world's leading 'classroom to
clinic' ultrasound companies, specialising in real-time hi-fidelity virtual
reality simulation for the ultrasound training market ('classroom') and
artificial intelligence-based clinical image analysis software tools for the
diagnostic medical ultrasound market ('clinic'). Based in Cardiff in
the UK and Atlanta in the US, the Group has two revenue streams:
Simulation
Real-time hi-fidelity ultrasound education and training through simulation.
Our main products are the ScanTrainer obstetrics and gynaecology training
simulator, the HeartWorks echocardiography training simulator,
the BodyWorks Eve Point of Care and Emergency Medicine training simulator
with Covid-19 module and the new BabyWorks Neonate and Paediatric training
simulator. To date over 1,400 simulators have been sold to c. 700 medical
institutions around the world.
Clinical AI software
Deep learning-based algorithms to make ultrasound machines smarter and more
accessible using our proprietary ScanNav ultrasound image analysis technology.
Current products on the market utilising this technology are GE
Healthcare's SonoLyst software that is incorporated in their Voluson Expert
22 and SWIFT ultrasound machines; ScanNav Anatomy PNB that simplifies
ultrasound image interpretation by providing the user with real-time AI-based
anatomy highlighting for a range of ultrasound guided regional anesthesia
procedures; and NeedleTrainer that teaches real-time ultrasound-guided
needling and incorporates ScanNav Anatomy PNB.
www.intelligentultrasound.com (http://www.intelligentultrasound.com/)
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