Processing Tool for Marrow Cleared
The MarrowExpress (MXP) device from ThermoGenesis Corporation was cleared for marketing (pdf) by the Food and Drug Administration. The system is utilized in the clinical laboratory setting or intraoperatively for processing of cell concentrates from bone marrow. The company also recently received the CE mark, allowing marketing across Europe.
The MXP is an iteration of the AutoXpress (AXP) Platform. That device is utilized for umbilical cord blood collection, as well as volume reduction.
The company plans to aggressively market the tool to orthopaedic practitioners, as well as vascular surgeons. More and more of those clinicians are beginning to process bone marrow stem cells.
The company previously submitted its 510(k) pre-market notification to the FDA for the MXP. The device was exempt from pre-market notification requirements. As such, the system will be monitored by the FDA as laboratory equipment indicated for a specific use.
ThermoGenesis develops and manufactures automated blood processing systems. The company further offers disposable products to support preservation, manufacture, and delivery of tissue and cell therapy products.
July 16, 2008 Related topics: Ethics & Scandals