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FDA Approvals - ThermoGenesis Corp. Submits 510(k) Application To FDA For AutoXpress(TM) Cord


ThermoGenesis Corp. Submits 510(k) Application To FDA For AutoXpress(TM) Cord Blood Processing System (Medical News Today)
ThermoGenesis Corp. (Nasdaq: KOOL) announced today that the Company has submitted a 510(k) pre-market notification application to the U.S. Food and Drug Administration (FDA) requesting regulatory clearance for its AutoXpress System (AXP(TM)). The AXP automates the isolation and capture of stem cells from umbilical cord blood in a functionally closed system. [click link for full article]

FDA Coalition Seeks Increases to Agency Budget (U.S. Newswire via Yahoo! News)
The Coalition for a Stronger FDA commended HHS Secretary Michael Leavitt and FDA Commissioner Andrew Von Eschenbach for increases in the Food and Drug Administration's fiscal year 2008 budget request and said it would work with Congress to include additional funding to ensure the agency is able to protect American patients and consumers.
 

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