FORT MILL, SC / ACCESSWIRE / March 20, 2023 / Ra Medical Systems, Inc. (NYSE American:RMED) announced today that its wholly owned subsidiary, Catheter Precision, Inc., has registered its leading product, VIVO, in Switzerland and has completed first cases in the new territory.
VIVO has already received FDA Clearance and successful registration with a German Competent Authority and MHRA registration allowing VIVO to be sold in the US, twenty-three countries within the European Union and the UK. For manufacturers based outside of Switzerland it is necessary to have a CH REP, or Swiss Authorized Representative, prior to marketing their medical devices in Switzerland.
David Jenkins, CEO and Chairman of the Board, says, "Our strategy in Europe has been to commercialize in areas that accept approvals from our existing competent authorities and to engage distributors where appropriate based physician interest. At the end of 2022, we had interest from physicians in Switzerland to use and purchase VIVO, so we began the process of engaging a Swiss Authorized Representative. We are pleased that we have now completed this process and have begun a successful evaluation with another hospital scheduled to begin later this month."
Catheter Precision's VIVO™ (View Into Ventricular Onset), is a non-invasive 3D imaging system that enables physicians to identify the origin of ventricular arrhythmias pre-procedure, thereby streamlining workflow and reducing procedure time. VIVO has received marketing clearance from the U.S. FDA and has the CE mark.
About Ra Medical Systems
Ra Medical, and its wholly owned subsidiary Catheter Precision, is an innovative U.S.-based medical device company bringing new solutions to market to improve the treatment of cardiac arrhythmias. It is focused on developing groundbreaking technology for electrophysiology procedures by collaborating with physicians and continuously advancing its products.
At the Company
SOURCE: Ra Medical Systems, Inc.