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news.ThermoGenesis has submitted a 510(k) pre-market notification application to the FDA requesting regulatory clearance for its MarrowXpress, a device designed for the processing of bone marrow in a laboratory setting.
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The device is a derivative of the company’s approved AutoXpress platform that is used to volume reduce and collect stem cells from umbilical cord blood.
William Osgood, CEO of ThermoGenesis, said: “This is an important milestone in the company’s product diversification and growth strategy. We are hopeful that the regulatory process will be facilitated because the MarrowXpress is based on a currently approved device.
The company expects to receive a CE mark for the MarrowXpress in June 2008, which would enable the company to begin commercial marketing of the device in Europe.”