Magnetecs CGCI Receives CE Marking for Sales in Europe
INGLEWOOD, Calif. – Magnetecs Corporation, a designer and manufacturer of robotic catheterization control systems for minimally invasive surgical procedures, today reported that the company’s Robotic Catheter Guidance Control and Imaging™ (CGCI) System has received CE Marking certification.
CE Marking will enable commercialization of CGCI in Europe and support certification in many other parts of the world. The scope of the indication for CGCI’s CE Marking is “Design, manufacture and installation of CGCI System to navigate a magnetic device to designated target sites. Design and manufacture of Catheter Impedance Seeking Device (CISD) as an accessory to CGCI.”
“CE Marking is the key achievement of Magnetecs required to transition from the development phase of our organization to building a commercial enterprise,” said Josh Shachar, CEO of Magnetecs Corporation. “The scope of the indication we have received will enable widespread application of our technology for electrophysiology and interventional cardiology as well as additional fields of use.”
STRONG CGCI SALES PIPELINE IN EUROPE
CE Marking will enable Magnetecs to generate revenue from sales in Europe in countries that include the U.K., Czech Republic, Sweden, Italy, Germany, Switzerland, and Russia. Magnetecs is planning additional installations in North America in Montreal, Canada, Utah, and New York City in anticipation of the company’s FDA 510(k) submission.
