CE Assurance Certificate
In December of 2011, the CGCI System received CE Marking certification. CE Marking enables the 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 required to transition from the development phase of the technology to building a commercial enterprise,” said Josh Shachar, CIO of Neuro-Kinesis. “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.”
CE Marking enables the CGCI platform to be commercialized in countries that include the U.K., Czech Republic, Sweden, Italy, Germany, Switzerland, and Russia