FDA clears CellaVision® Body Fluid Application for the CellaVision® DM1200 Cell Morphology System
September 29, 2011 — CellaVision, which develops and sells products for routine analysis of blood and other body fluids in health care, has received clearance by the FDA to market and sell its application for analysis of body fluids, for use with the company’s cell morphology system for medium-sized laboratories, the CellaVision® DM1200. By using the application, clinical laboratories are able to analyze spinal fluid, synovial fluid and pleural fluid among other body fluids.
To assess blood cells in body fluid samples is a complicated procedure in clinical laboratories, requiring years of experience. CellaVision® Body Fluid Application helps to streamline the process and to increase the quality of test results.
“We see a great need among our customers for the type of functions that CellaVision’s automated products can now offer. To analyze blood and other body fluids quickly and effectively is an ideal solution for many laboratories, especially as the supply of qualified Medical Technologists is in rapid decline” said Ron Hagner, Vice President Sales and Business Development at CellaVision North America. “Having received the FDA clearance for our CellaVision® Body Fluid Application, allows us to now offer medium-sized laboratories a fully automated analyzer for both blood and other body fluids incorporating features that will help them to become best practice in cell morphology.”
CellaVision’s current product portfolio includes, CellaVision® DM96 and CellaVision® DM1200 systems for cell morphology for large and medium-sized laboratories, as well as applications for analysis of blood and other body fluids, remote review and competency/education. The CellaVision solution promotes cooperation between related laboratories and provides a platform for laboratories to achieve efficient, reliable morphological classification resulting in streamlined patient care.
In the United States CellaVision products are sold by both the subsidiary CellaVision Inc. as well as through their distribution partners, Sysmex America Inc. and Beckman Coulter Inc. The CellaVision Body Fluid Application has been available for use on the CellaVision DM96 since 2008, and on the CellaVision DM1200 outside the US since 2010.
• Automated location and pre-classification of nucleated cells into seven cell classes
• Digital scan of entire sample area in 10x and 50x
• Share cell images and Regions of Interest with colleagues
• Images can be stored and accessed by any PC using CellaVision Remote Review Software
• Fast and efficient user interface, similar to other CellaVision applications
• Throughput up to 15 slides/h
• Supports all standard Romanowsky Stains
• Body Fluid samples can be analyzed interspersed with blood samples for most efficient workflow
• LIS interface Bi-directional support
Utilizing a cytocentrifuge slide preparation, the CellaVision DM1200 automatically performs a preliminary differential of nucleated cells, and allows the user to scan the entire sample area. The pre-classified result requires verification by a Medical Technologist. When classification needs to be changed, cells can be dragged and dropped into the appropriate cell class.
Regions of Interest (ROI) can be tagged, comments added and images stored and shared anywhere on a network. Access to a patient’s historical images and real-time collaboration ensures the accuracy and standardization of the analysis.
For more information, please contact:
Ron Hagner, Vice President Sales and Business Development, CellaVision Inc.
Phone: (919) 619-3909. E-mail: email@example.com
CellaVision is an innovative, global medical technology company that develops and sells best-in-class systems for the routine analysis of blood and other body fluids. These analyses often provide critical results used in the diagnosis of a variety of illnesses such as infection and cancer. CellaVision’s products reduce manual laboratory work, standardize results and support an efficient laboratory workflow. The company has leading-edge expertise in digital image analysis, artificial intelligence and automated microscopy. In 2010, net sales were 132 MSEK and sales continue to grow with the target to increase by at least 15 percent per year over an economic cycle. CellaVision has its head office in Lund, Sweden, and subsidiaries in the US, Canada and Japan. The company share is listed on Nasdaq OMX Stockholm, Small Cap. Read more at www.cellavision.com
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