FDA clears BioSphere's coloured microspheres:
This article was originally published in Clinica
Executive Summary
BioSphere Medical has gained US FDA 510(k) clearance to market its coloured microspheres for use during embolotherapy, a procedure for occluding the blood supply to diseased tissue. The EmboGold product, available in a pre-filled syringe, is designed to improve a doctor's ability to visualise and handle the microspheres, thereby facilitating a controlled, targeted embolisation, says the Rockland, Massachusetts, firm. BioSphere plans to launch the product in the third quarter.