Cardiac Pathways submits Tracking system to FDA:
This article was originally published in Clinica
Executive Summary
Cardiac Pathways has filed a 510(k) application with the US FDA to market a range of products based on its Tracking System technology. The system can help visualise the position of multiple electrophysiology catheters in the heart simultaneously, in three-dimensions and in real-time without the aid of fluoroscopy. It consists of a line of diagnostic catheters, which contain ultrasound transducers that triangulate, in real-time, their position within the heart, and a computer system that combines real-time, three-dimensional graphics, displaying catheter images while recording the associated intracardiac electrical signals, said the Sunnyvale, California-based company.