Ra Medical Systems Announces Expansion to New European Territory

Rhea-AI Summary

Ra Medical Systems (NYSE American:RMED) announced the registration of its product, VIVO, in Switzerland through its subsidiary, Catheter Precision, Inc. This follows VIVO's prior approvals from the FDA, German Competent Authority, and MHRA, enabling sales in the US, EU, and UK. CEO David Jenkins reported burgeoning physician interest from Switzerland, leading to the engagement of a Swiss Authorized Representative. The system offers a non-invasive 3D imaging solution for identifying ventricular arrhythmias, aimed at improving workflow and reducing procedure times. VIVO’s market entry signifies strategic growth and capitalizes on existing certifications.

Positive

• Completion of VIVO registration in Switzerland expands market potential.
• CEO highlights strong physician interest, indicating demand for VIVO.
• VIVO is already FDA cleared and has CE marking, ensuring regulatory compliance.

Negative

• None.

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."

About VIVO

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.

CONTACTS:

At the Company
David Jenkins
973-691-2000
mhuck@catheterprecision.com

SOURCE: Ra Medical Systems, Inc.

View source version on accesswire.com:
https://www.accesswire.com/744554/Ra-Medical-Systems-Announces-Expansion-to-New-European-Territory

FAQ

What recent development has Ra Medical Systems (RMED) announced regarding VIVO?

Ra Medical Systems announced the registration of its product VIVO in Switzerland, allowing for its sales in the new territory.

What approvals has VIVO received prior to its registration in Switzerland?

VIVO has received FDA clearance, as well as registration from the German Competent Authority and MHRA.

How does VIVO benefit medical procedures?

VIVO provides a non-invasive 3D imaging system that helps identify the origin of ventricular arrhythmias, which streamlines workflow and reduces procedure time.

What strategic move did Ra Medical Systems make in Europe for VIVO?

The company engaged a Swiss Authorized Representative to facilitate VIVO's entry into the Swiss market, following physician interest.