New Body Fluid Application for the CellaVision DM96 now cleared for sale in the US
The application improves the efficiency, standardization and connectivity of a difficult microscopic procedure
CellaVision AB (publ), which develops and sells digital morphology products, has received clearance by the Food and Drug Administration (FDA) to market and sell its CellaVision® Body Fluid Application, in the US.
"The FDA clearance of our body fluid application will both increase the utility of the CellaVision DM96 analyzer and the product portfolio available to both new and existing customers on the US market, and will reflect positively on our sales," says Yvonne Mårtensson, CEO of CellaVision. "Additionally, FDA clearance is also very important to many markets outside the US."
The CellaVision® Body Fluid Application runs on the analyzer CellaVision® DM96. Most laboratories already using the analyzer for blood differentials are also analyzing other body fluids, such as cerebrospinal fluid and pleural fluid. The benefits are similar to the company's blood application, namely quicker and more standardized results, digital archiving of test results with cell images, as well as sharing of digital images with experts outside the laboratory.
CellaVision's products are sold direct in the US by the subsidiary CellaVision Inc. and are also distributed by Sysmex America. All CellaVision DM96 analyzers that are already installed in the US form potential bases for the body fluids application. The CellaVision® Body Fluid Application is already available in Europe and Canada.
For more information, please contact:
Yvonne Mårtensson, CEO, CellaVision AB
CellaVision AB develops, markets, and sells market leading image analysis based systems for routine analysis of blood and other body fluids. The company has a core competence in development of software and hardware for automatic image analysis of cells and cell changes for applications in health and medical care. The company develops and markets systems for automatic differentials of white blood cells and red morphology, and software for education and quality assurance of differentials. The company's associates have expertise in advanced imaging analysis, artificial intelligence, and automated microscopy.
The company headquarters are in Lund, Sweden. The company also has subsidiaries in Florida, USA, Toronto, Canada and Yokohama, Japan. For more information, visit www.cellavision.com
CellaVision's share is listed on First North at the OMX Stockholm Stock Exchange. The company's Certified Advisor is Remium AB.