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INTELLIGENT ULTRASOUND GROUP PLC
Regulatory Filings • Oct 30, 2020
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Regulatory Filings
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National Storage Mechanism | Additional information 
RNS Number : 6899D
Intelligent Ultrasound Group PLC
30 October 2020
Intelligent Ultrasound Group plc
("Intelligent Ultrasound" or the "Group")
GE Healthcare's Voluson SWIFT receives 510(k) clearance from the FDA
Intelligent Ultrasound (AIM: MED), the artificial intelligence (AI) based ultrasound software and simulation company, announces that GE Healthcare's Voluson SWIFT ultrasound machine that incorporates GE Healthcare's SonoLyst software with Intelligent Ultrasound's ScanNav Assist AI technology, has received 510(k) clearance from the FDA for sale in the USA.
SonoLyst is 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 and features two applications that leverage Intelligent Ultrasound's technology, SonoLystIR and SonoLystX.
SonoLystIR performs automated detection of the key scanning views and automated selection of the relevant Voluson SonoBiometry measurement tools; and SonoLystX, a virtual on-board ultrasound expert, uses AI to compare the acquired image to standardised criteria, to ensure that it meets clinical standards. SonoLystX can help enhance accuracy and quality and is ideal for teaching, training and quality assurance to ensure the highest quality image standards and consistency.
SonoLyst is the first AI software to be launched under the Group's long-term licence and co-development agreement with GE Healthcare that enables the integration of Intelligent Ultrasound's real-time AI image analysis software into GE Healthcare's Voluson women's health ultrasound portfolio. The first royalty per unit revenues for Intelligent Ultrasound are expected at the start of 2021.
Nicholas Sleep, CTO of Intelligent Ultrasound, said: "SonoLyst is an exciting new scanning aid in women's healthcare and FDA clearance for the Voluson SWIFT opens up the important US market. We are delighted to be working with GE Healthcare to bring the latest AI innovations to the global ultrasound market."
The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014. Upon the publication of this announcement via a Regulatory Information Service ("RIS"), this inside information is now considered to be in the public domain.
For further information, please contact:
| Intelligent Ultrasound Group plc | www. intelligentultrasound.com | ||
| Stuart Gall, CEO Helen Jones, CFO |
Tel: +44 (0)29 2075 6534 | ||
| Cenkos Securities - Nominated Advisor and Broker | Tel: +44 (0)20 7397 8900 | ||
| Giles Balleny / Cameron MacRitchie (Corporate Finance) | |||
| Michael Johnson / Julian Morse (Sales) | |||
| Walbrook PR | Tel: +44 (0)20 7933 8780 or [email protected] | ||
| Anna Dunphy / Paul McManus | Mob: +44 (0)7876 741 001 / Mob: +44 (0)7980 541 893 | ||
About Intelligent Ultrasound Group
Intelligent Ultrasound (AIM: MED) develops artificial intelligence-based clinical image analysis software tools for the diagnostic medical ultrasound market and hi-fidelity virtual reality simulators for the ultrasound training market.
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