FDA panel to review Carticel in March
This article was originally published in Clinica
Executive Summary
The US FDA's orthopaedic and rehabilitation devices panel plans to review Genzyme Tissue Repair's Carticel on March 6th. The Carticel service grows a patient's own cartilage cells for knee repair surgery. It has been sold unregulated since July 1995 when it was reviewed by the FDA and found to fall outside existing regulations.