CellaVision, Lund, Sweden receives FDA clearance for the CellaVision(TM)DM96 Digital Cell Morphology System.

19-Feb-2004

CellaVision AB announced that the CellaVision DM96 automated digital cell morphology system has been cleared by the food and Drug Administration for sale in the United States. The FDA clearance was received one month earlier than originally expected. The CellaVisionDM96 is the Next Generation of the company's first product DiffMaster(TM) Octavia. The CellaVisionDM96 locates and pre-classifies blood cells by means of automatic microscopy and advanced image processing, resulting in greater efficiency and standardization of the blood differential process.

"We are very happy to receive the FDA clearance so fast. It is very important to CellaVision to introduce the product in the U.S. Early market feedback has been extremely enthusiastic, and we expect to have a significant number of laboratory sites using the DM96 in day-to-day routine before the end of the year," says Yvonne M?rtensson, CEO, CellaVision AB.

The CellaVision(TM)DM96 was successfully introduced in Europe in late 2003. The product will be formally launched in the U.S., at the CLMA/ASCP 2004 Annual Conference and Exhibition in Atlanta, Georgia. March 28-30, and can be seen in the Sysmex America exhibit booth.

In December, Sysmex America Inc. and CellaVision AB signed an exclusive distribution agreement giving Sysmex the right to sell, market and support the CellaVision(TM)DM96 to hematology laboratories in the United States. CellaVision Inc., Jupiter, FL, a subsidiary to the Swedish company CellaVision AB, will provide support to Sysmex America while continuing to supply and support existing CellaVision MICRO21 and DiffMaster customers.

https://www.bionity.com/en/news/35476/cellavision-lund-sweden-receives-fda-clearance-for-the-cellavision-tm-dm96-digital-cell-morphology-system.html