Medovex has successfully completed its final CE Mark audit meeting to acquire certification for the DenerveX system. The audit is required to demonstrate compliance with the regulatory requirements to achieve CE Mark approval.
Upon successfully completing this audit, the CE certificate would generally be expected to be issued paving the way to the future launch of the DenerveX System in the EU and other countries which accept the CE Mark.
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. DenerveX system is not yet CE marked or FDA cleared and is not yet commercially available.