Magnetecs announced CE mark approval for its Robotic Catheter Guidance Control and Imaging system (CGCI) for electrophysiological procedures.
The Catheter Guidance Control and Imaging system allows 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, the 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.
The CGCI system is integrated with sophisticated cardiac mapping and navigation technologies, including X-ray, intracardiac echocardiography, and other advanced electrophysiology lab technologies and equipment. Magnetecs is planning additional applications of this electromagnetic technology in the fields of interventional cardiology, gastroenterology, neurology, and gynecology.
“CE marking is the key achievement of Magnetecs required to transition from the development phase of our organisation to building a commercial enterprise,” said Josh Shachar, CEO of Magnetecs. “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.”
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.