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DIAGNOS Announces Issuance of CE Certificate for CARA Commercialization(November 30, 2011)
BROSSARD, QUEBEC, CANADA -- (Marketwire) -- 11/30/11 -- DIAGNOS inc. ("DIAGNOS" or the "Corporation") (TSX VENTURE:ADK), a leader in the use of knowledge discovery and artificial intelligence tools, announced today the issuance of a CE certificate (CE marking) under European directives applicable to medical devices to commercialize CARA in the European Union.
CARA satisfied the requirements of article 14 of Directive 93/42/CEE concerning medical devices and is now officially registered. This new certification for the European Union also adds to the collection of both compliance and regulatory certifications that DIAGNOS has obtained in the past 12 months for CARA, particularly ISO 9001 certification, ISO 13485 certification, Health Canada certification of a medical instrument, that of the Canadian Medical Devices Conformity Assessment Scheme (CMDCAS) and, most recently, approval of CARA by the FDA. "This marking by the respective competent authorities is further proof of the credibility and seriousness of the design and development of the CARA product and a new key to facilitating the sales process and our negotiations with parties interested in this new market for DIAGNOS," said Houssem Ben Tahar, Vice-President Development and the person responsible for regulations at DIAGNOS.
According to the World Health Organization, 48 million people will have diabetes in the European Region by 2030, and reducing the burdens of the disease and the severity of its complications is a key concern for policy makers and health care practitioners. "The EU is a key market for our CARA platform and we are very pleased with this milestone for CARA as it will facilitate and accelerate bringing to closure our discussions with prospective clients and partners underway in several European countries," said Peter Nowacki, DIAGNOS' Vice-President Healthcare.
CARA is a tele-ophthalmology platform that integrates with existing equipment (hardware and software) and processes at the point of care (POC) and comprises: image upload, image enhancement automated pre-screening, grading by a specialist and referral to a specialist. CARA is accessible securely over the Internet and is compatible with all recognized image formats and brands of fundus cameras. CARA is a cost-effective tool for processing large numbers of images, in real-time, and is now licensed for commercialization in Canada, the US and Europe.
Founded in 1998, DIAGNOS is a publicly traded Canadian corporation (TSX VENTURE:ADK) with a mission to commercialize technologies combining contextual imaging and traditional data mining, thereby improving decision making processes. DIAGNOS offers products, services and solutions to clients in a variety of fields including healthcare, natural resources and entertainment.
Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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