2023-03-20 08:24:46 ET
- Ra Medical Systems ( NYSE: RMED ) has announced that its wholly owned subsidiary, Catheter Precision, 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.
- "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." David Jenkins, CEO and Chairman of the Board.
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Ra Medical Systems announces expansion to new European territory