(Alliance News) - Intelligent Ultrasound Group PLC on Wednesday said it has received ISO13485:2016 certification in the UK for its Quality Management System, taking it a step closer to regulatory approval.
Shares in Intelligent Ultrasound were up 40% at 14.00 pence in London shortly before midday.
The certification was awarded after review by Lloyds Register Qaulity Assurance Ltd, a certification body. Intelligent Ultrasound described ISO13485:2016 as "the internationally recognised quality standard to ensure the consistent design, development, production, installation and sale of medical devices".
Intelligent Ultrasound develops software tools which use artificial intelligence to analyse clinical images. Its Clinical AI division is currently working to bring its software products to market and the ISO13485:2016 is required to get regulatory approval for the products.
Clinical AI products include ScanNav, used to assess ultrasounds in fetal medicine, and AnatomyGuide - intended "to simplify ultrasound-guided needling".
Stuart Gall, Intelligent Ultrasound's chief executive, said: "With our first major AI licensing agreement signed last year and commercial discussions progressing for our second AI software product, this is an important milestone for the group as we look to bring the first Intelligent Ultrasound AI products to market in 2020."
By Anna Farley; annafarley@alliancenews.com
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