CellaVision's new analyzer receives FDA clearance for the US market
(Thomson Reuters ONE) - CellaVision AB (publ), which develops and sells digital morphologyproducts for the routine analysis of blood and other body fluids, hasreceived clearance by the Food and Drug Administration (FDA) tomarket and sell its new analyzer CellaVision® DM1200 in the US. Thenew product is expected to stimulate growth in the US market."The FDA's clearance is an important step in our focus on the NorthAmerican market," says Yvonne Mårtensson, CEO for CellaVision. "TheFDA clearance came earlier than expected, which means that we canstart marketing and selling the product to customers in the USalready during the first quarter of 2010. The CellaVision DM1200 is afully automated analyzer aimed at medium-sized hospitals contributingto a more efficient workflow. We expect this value to increase salesin the US market."Since the third quarter this year, CellaVision® DM1200 iscommercially available in Europe and Canada. The product is intendedto replace manual microscopy of blood samples and is aimed atmedium-sized hospital laboratories as well as independent commerciallaboratories. The distribution between different types of blood cellsand their appearances are important criteria in the diagnosis of anumber of conditions such as infections and blood diseases. Automatedtechnology permits to increase productivity, reduce response times,and improve diagnostic quality.North America is one of CellaVision's major growth markets.CellaVision's products are sold in the US by the company's own salesorganization in parallel with the distributor Sysmex America. InCanada the products are sold through CellaVision's own salesorganization. During 2008 the North American market accounted for 43percent of CellaVision's total turnover.For more information, please contact:Yvonne Mårtensson, CEO, CellaVision ABPhone: +46 708 33 77 82. E-mail: yvonne.martensson(at)cellavision.comAbout CellaVisionCellaVision AB develops, markets, and sells market leading imageanalysis based systems for routine analysis of blood and other bodyfluids. The company has a core competence in development of softwareand hardware for automatic image analysis of cells and cell changesfor applications in health and medical care. The company develops andmarkets systems for automatic differentials of white blood cells andred morphology, and software for education and quality assurance ofdifferentials. The company's associates have expertise in advancedimaging analysis, artificial intelligence, and automated microscopy.The company headquarters are in Lund, Sweden. The company also hassubsidiaries in Florida, USA, Toronto, Canada and Yokohama, Japan.For more information, visit www.cellavision.com.CellaVision's share is listed on First North Premier at the OMXStockholm Stock Exchange. The company's Certified Advisor is RemiumAB.This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
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