FDA clears ThermoGenesis' MarrowXpress
This article was originally published in Clinica
The US FDA has cleared ThermoGenesis' MarrowXpress system, which isolates stem cells from bone marrow, for use in a clinical laboratory setting or during operations. The Rancho Cordova, California firm submitted a 510(k) application to the agency last month, but the FDA determined MarrowXpress was exempt from these requirements – instead it will be regulated as laboratory equipment labelled for a specific use. ThermoGenesis CE marked the product, which is based on its AutoXpress platform, for sale in Europe last month. Bone marrow-derived stem cells are used in clinical trials in areas including blood disorders, ischaemic heart disease, peripheral artery disease and diabetes, and in orthopaedic and vascular surgeries.