ATLANTA, GA–(Marketwired – Jan 3, 2017) – Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, today announced that the Company has successfully received certification of compliance for its DenerveX™ System from SGS S.A. a Swiss based multinational testing and certification firm. Compliance testing included electrical safety testing for US, Canada and the European Union.
SGS is the world’s leading inspection, verification, testing and certification company, recognized as the global benchmark for quality and integrity. With more than 85,000 employees, SGS operates a network of more than 1,800 offices and laboratories around the world. SGS core services can be divided into four categories including Inspection, Testing, Certification and Verification.
Patrick Kullmann, Medovex President and COO, stated, “We’re very pleased that the DenerveX System has successfully received SGS certification. This is the most significant development milestone that Medovex has accomplished since the company was founded and is the most important to date leading up to CE Marking of the system for sale outside of the U.S.”
Kullmann went on to state “This very stringent testing and certification validates that the DenerveX System is electrically safe to use on humans in a clinical setting. Testing covered by this certification include IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-2. The IEC 60601-1 testing standard is the global benchmark for electrical medical equipment and contains requirements concerning basic safety and essential performance. The IEC 60601-2-2 testing standard covers the particular requirements for high frequency surgical equipment and high frequency surgical accessories. And the IEC 60601-1-2 testing standard covers Electromagnetic Compatibility (EMC).”
Dennis Moon, Medovex Executive Vice President, indicated that “the SGS certification is accepted by both the international and U.S. communities as the gold standard in safety testing of electrical based medical devices and it will be a very important part of our application for CE Marking of the DenerveX System.”
The DenerveX System consists of the DenerveX device, a single use medical device and the DenerveX Pro-40 Power Generator, both designed to be less invasive with faster recovery time than current surgical treatment options. It consists of two procedures combined into one device and is expected to provide for a longer lasting treatment solution while offering potential savings to the health care system. DenerveX is not yet commercially available.
DenerveX system is not yet CE marked or FDA cleared and is not yet commercially available.
Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com
Safe Harbor Statement
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