Magnetecs CGCI Receives CE Marking for Sales in Europe
Published: Dec 16, 2011
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 Catheter Guidance Control and Imaging (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.”
Below is the Magnetecs Regulatory Team, under the direction of David Johnson, Vice President and Director of Software Engineering, responsible for the CE Marking Certification.
Magnetecs Regulatory Team
Dr. Eli Gang, M.D., FACC, FACP, Chief Medical Officer
David Johnson, Vice President, Director of Software Engineering
Bruce Marx, Vice President, Director of Real-Time and Control Software
Shawn Hakim, Vice President, Director of Mechanical Engineering
Jonathan Tengco, Lead Software Engineer
Danielle Fluster, Quality Assurance Designee
Paladin Luboff, Technical Writing Supervisor, Quality Assurance Designee
Laszlo Farkas, Chief Scientist
Robert Beck, Regulatory affairs
Jack Slovick, Regulatory Affairs
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.
CGCI is a unified system for robotic guidance, control and imaging of catheters and other advanced tools used in electrophysiological and other procedures. Previous magnetic guidance systems use large, independent magnets which emit a substantial and continuous magnetic field, have limited control capabilities, and require shielding. In contrast, Magnetecs’ CGCI system creates an electromagnetic field that is largely contained in the electromagnetic array and focused in an area no larger than the patient’s chest. CGCI only emits a magnetic field when in use and can dynamically adjust and manipulate this field to safely and reliably achieve unprecedented three-dimensional catheter-guidance precision and responsiveness.
The CGCI system is integrated with sophisticated cardiac mapping and navigation technologies, including X-ray, intracardiac echocardiography (ICE), and other advanced electrophysiology lab technologies and equipment. Magnetecs is planning additional applications of the Company’s electromagnetic technology in the fields of interventional cardiology, gastroenterology, neurology, and gynecology.
Magnetecs Corporation designs and manufactures a unique and highly efficient robotic catheterization control system for minimally invasive surgical procedures and the advanced specialized tools used in these procedures. The Company believes that its proprietary Catheter Guidance Control and Imaging (CGCI) system will greatly improve the efficacy, safety and cost efficiency of many common minimally invasive surgeries. Magnetecs has established advanced electrophysiology surgical suites for CGCI development and testing at the Company’s headquarters facility in Inglewood, California. For additional information on CGCI and Magnetecs Corporation, please visit the Company’s website at www.magnetecs.com.
Daniel Saks, Senior Vice President, Corporate Affairs