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Microbot Medical Engaging with a Leading Notified Body to Advance CE Mark for Sales in Europe
Engagement includes audit plans for ISO 13485 certification, to pave the way for obtaining CE Mark for clearance of sales in the European Union HINGHAM,
About this update from Microbot Medical Inc.
[{"type":"text","content":"Engagement includes audit plans for ISO 13485 certification, to pave the way for obtaining CE Mark for clearance of sales in the European Union\nHINGHAM, Mass., July 25, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), the developer of the LIBERTY® Robotic Surgical System, the first single-use endovascular robotic system, today announced the first steps towards its planned European market clearance, by engaging with a leading Notified Body. The Notified Body will audit the Company to verify the compliance of its quality management system and the quality of the LIBERTY Robotic Surgical System development with widely acceptable standards in the medical device industry. In addition, preparations are being made to obtain EU-MDR certification (European Medical Devices Regulation) leading to CE mark, which would allow the Company to sell the LIBERTY Robotic Surgical System throughout the European Union. “Following the success of multiple pre-clinical studies conducted with the participation of leading European-based interventional radiologists, Microbot is now expanding to seek a wider range of potential users in key growth markets,” commented Harel Gadot, Chairman, President and CEO. “We believe the LIBERTY Robotic Surgical System has the potential to revolutionize the way catheterization is being done today, by providing a single-use system designed to provide a high degree of stability, as demonstrated in our pre-clinical studies.” About Microbot Medical Microbot Medical Inc. (NASDAQ: MBOT) is a pre-clinical medical device company that specializes in transformational micro-robotic technologies, with the goals of improving clinical outcomes for patients and increasing accessibility through the natural and artificial lumens within the human body. The LIBERTY® Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures today, by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company believes the LIBERTY® Robotic Surgical System’s remote operation has the potential to be the first system to democratize endovascular interventional procedures.Further information about Microbot Medical is available at http://www.microbotmedical.com. Safe Harbor Statements to future financial and/or operati...