A month ago we reported that the EU has given approval to ThermoGenesis Corp. (Rancho Cordova, CA) to market the company’s MarrowXpress device, which isolates and concentrates stem cells from bone marrow aspirate. Today’s news is that the FDA has classified the device as a piece of laboratory equipment for medical use, and approved it for sale in the US.
Last month, the Company announced it had submitted a 510(k) pre-market notification application to the FDA. Upon its review, the FDA determined that the device was exempt from the agency’s pre-market notification requirements and will instead be regulated as laboratory equipment labeled for a specific medical use. The device is a derivative of the Company’s AutoXpress™ (AXP™) Platform that is used to volume reduce and collect stem cells from umbilical cord blood.
“This notification that we can immediately begin marketing our MXP device is a major regulatory milestone for the Company and particularly exciting since we received this notification just several weeks after filing our submission, and since it follows by less than a month from having received the CE-Mark enabling us to market the device in the European Community,” noted Dr. William Osgood, Chief Executive Officer.
Press release: THERMOGENESIS ANNOUNCES FDA AUTHORIZATION TO MARKET MARROWXPRESS™ (MXP™) (PDF)
Product page: MarrowXpress…
Flashback: MarrowXpress Stem Cell Processing System Gets CE Mark