Brighton, Michigan, 6th April, 2018 – FlexDex™ is pleased to announce that it has secured approval to affix the CE Mark on its first product. The CE Mark is a certification symbol in Europe that signals conformity to patient and user safety and device performance standards in the region. The certification mark is considered an essential requirement for companies intending to sell medical products in the European Economic Area without restrictions. Many large medical device markets in Europe are poised to begin offering FlexDex where there is pent-up demand for FlexDex’s affordable surgeon powered robotic platform.
FlexDex will also leverage the CE Mark to access new markets outside of the EU in the near future. FlexDex is already being marketed in Japan and Brazil, two of the largest medical device markets in the world. From its inception, FlexDex’s mission has been to substantively expand the use of its laparoscopic devices. This would enable surgeons to employ robotic techniques anywhere in the world, at any time, bringing the benefits of Minimally Invasive Surgery (MIS) to more patients around the world.
FlexDex’s MIS technology platform has been hailed as a revolutionary innovation that delivers robotic precision in surgical procedures at significantly lower costs. This latest CE Mark certification heralds yet another step forward in FlexDex’s efforts to deploy its innovations on a global scale. More information on these developments is available at: https://flexdex.com/.
About FlexDex, Inc.
FlexDex is a medical technology start-up created by University of Michigan Professors Shorya Awtar, Sc.D. and James Geiger, MD. The company, based in Brighton, MI, is developing and commercializing a suite of articulating laparoscopic instruments for minimally invasive surgery. Via fundamental innovations in parallel kinematics, Virtual Center™, and flexure mechanisms, the company has created an innovative MIS technology platform designed to provide similar benefits as computer aided surgery, using low-cost high-performing devices.
James Geiger, MD
Chief Executive Officer