Electrophysiology equipment developer EPMedSystems has submitted a 510(k) filing with the U.S. Food and Drug Administration for regulatory approval of its ViewMate intracardiac ultrasound catheter system. The system allows physicians to view the interior anatomy of the heart, enabling diagnosis and treatment of a number of heart abnormalities, according to the West Berlin, NJ-based firm.
The FDA filing marks the second step in the company’s attempts to globalize the system. In January 2003, it filed with the European Notified Body for regulatory approval to affix the CE Mark onto the platform that will permit ViewMate sales to the European Community.
By AuntMinnie.com staff writersApril 4, 2004
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