FDA clears ThermoGenesis' MarrowXpress
This article was originally published in Clinica
Executive Summary
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.