LONDON (Alliance News) - Cambridge Cognition Holdings PLC said Thursday that it has submitted its CANTAB Mobile product to the US Food & Drug Administration for clearance as a medical device.
This product was developed to detect episodic memory impairments in early stage Alzheimer's disease patients aged over 50.
The company said that, following its establishment of a commercial team in the US in 2015 to drive sales, this submission markets the "first step" in broadening out its healthcare technologies into the American market.
"Having demonstrated the clinical efficacy and feasibility of CANTAB Mobile within the UK National Health Service it is our intention to broaden the commercialisation of our healthcare products outside of Europe, particularly in the North American markets. Submission of the first Cambridge Cognition product for FDA clearance is a significant landmark as we continue to develop solutions to address this significant and growing market," said Chief Executive Officer Steven Powell in a statement.
Shares in Cambridge Cognition were down 3.8% at 38.00 pence Thursday morning.
By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
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