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510(k) for EP MedSystems' SilverFlex technology:

This article was originally published in Clinica

Executive Summary

EP MedSystems has received US FDA clearance for its new range of silver-coated electrophysiology catheters used in the diagnosis and treatment of cardiac disorders. The Mount Arlington, New Jersey-based company says the advantages of the SilverFlex technology, which was used for coating the catheter tube with a very thin layer of silver, includes flexibility, conductivity and a manufacturing cost savings of up to 50% compared with standard hard metal electrodes. In addition, the technology allows a large number of electrodes to be placed on the catheter.

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