Atlanta-based Medovex Corp. received SGS' compliance certification for its DenerveX System.
Here are five insights:
1. SGS is a Switzerland-based multinational testing and certification firm.
2. The compliance testing encompassed electrical safety testing for the United States, Canada and the European Union.
3. Medovex President and COO Patrick Kullmann said this certification is a significant step toward achieving the CE Mark.
4. The DenerveX System includes the DenerveX device, a single-use medical device, and the DenerveX Pro-40 Power Generator.
5. The system is not CE marked or FDA cleared.