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news.ThermoGenesis has announced that TUV has issued an EC certificate for the MarrowXpress system, which allows the company to affix the CE mark and commence selling the product in the European community.
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ThermoGenesis’s MarrowXpress (MXP) device is used to process bone marrow in a laboratory setting. The MXP is a derivative of the company’s approved AutoXpress platform that is used to reduce volume and collect stem cells from umbilical cord blood.
Earlier June 2008, ThermoGenesis has submitted a 510(k) pre-market notification application to the FDA seeking regulatory clearance in the US.
William Osgood, CEO of ThermoGenesis, said: “We have had very encouraging feedback from a number of European centers at which bone marrow clinical trials are either underway or planned. With this approval, we can now ramp up those discussions and initiate a formal launch for the MXP in Europe.”