FDA clears Irvine's steerable catheters:
This article was originally published in Clinica
Irvine Biomedical has received US FDA 510(k) clearance to market its AFocus family of steerable diagnostic catheters for cardiac mapping. The devices are designed to help identify electrical potential in atrial structures of the heart. They incorporate a circular curve that is perpendicular to the catheter shaft, allowing for simultaneous, circumferential electrical recording, says the Irvine, California firm.