Followers | 16 |
Posts | 1295 |
Boards Moderated | 0 |
Alias Born | 11/15/2007 |
Wednesday, February 15, 2017 9:02:03 AM
ATLANTA, GA -- (Marketwired) -- 02/15/17 -- Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, today announced that the Company successfully completed its final CE Mark audit meeting. The review of the Company's DenerveX™ System was conducted February 7-9, 2017 by LNE/GMED, a French-based Notified Body firm. This audit is required to demonstrate compliance with the regulatory requirements to achieve CE Mark approval.
Related Links
Release PDF
Patrick Kullmann, Medovex President and COO, stated, "We're very pleased to have completed our certification audit of the DenerveX System February 7-9, 2017 at the Company's Atlanta based offices. Our in-house development team, along with several representatives from our world-class suppliers and consultants, contributed extensively during this process due to their vast expertise in R&D, manufacturing, electro-surgery, regulatory, quality, and sterilization processes."
Kullmann further stated, "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."
Previously on January 3, 2017, the Company announced it had 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.
Prior to that on November 3, 2016, the Company announced that it held a successful cadaver lab during NASS 2016. Medical advisory board members Martin Deeg, MD from Stuttgart, Germany, Vik Kapoor, MD from Manchester, England, as well as Gabriel Davila, MD from Colombia, Latin America, highlighted the DenerveX System. Thirty spine surgeons from Europe and Latin America attended the lab, both experiencing and using the device.
Jarrett Gorlin, Medovex CEO, commented, "I'm very proud of our team and how they prepared for and handled this important event. Together, we have spent countless hours in anticipation of meeting with representatives of LNE/GMED. Although a date has not been provided for the anticipated receipt of the CE certificate or the launch of the product, we believe we remain well on our way to completing the final regulatory step in the process of achieving CE Marking."
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, and is expected to provide for a longer lasting treatment solution while offering potential savings to the health care system.
DenerveX system is not yet CE marked or FDA cleared and is not yet commercially available.
Recent IVRN News
- Form 8-K - Current report • Edgar (US Regulatory) • 06/11/2024 02:26:30 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/22/2024 04:52:00 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 05/16/2024 09:22:02 PM
FEATURED Cannabix Technologies and Omega Laboratories Inc. Advance Marijuana Breathalyzer Technology - Dr. Bruce Goldberger to Present at Society of Forensic Toxicologists Conference • Sep 24, 2024 8:50 AM
FEATURED Integrated Ventures, Inc Announces Strategic Partnership For GLP-1 (Semaglutide) Procurement Through MedWell USA, LLC. • Sep 24, 2024 8:45 AM
Avant Technologies Accelerates Creation of AI-Powered Platform to Revolutionize Patient Care • AVAI • Sep 24, 2024 8:00 AM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM