Microbot Medical® Receives FDA 510(k) Clearance for Its LIBERTY® Endovascular Robotic System

Core Insights - Microbot Medical Inc. has received FDA 510(k) clearance for its LIBERTY Endovascular Robotic System, marking a significant milestone for the company and the endovascular robotics field [3][4] - The company aims to commercialize the LIBERTY System in the U.S. by Q4 2025, targeting an addressable market of approximately 2.5 million peripheral endovascular procedures annually [2][4] - The LIBERTY System demonstrated a 100% success rate in robotic navigation to target and a 92% relative reduction in radiation exposure for physicians during its pivotal study [4] Company Developments - The CEO, Harel Gadot, emphasized that the FDA clearance validates the company's mission to enhance access to advanced robotic technologies and supports cost-effective healthcare [4] - The company has been developing its commercial readiness strategy since Q2 2025, positioning itself to accelerate market entry following FDA clearance [4] - Microbot Medical plans to continue collecting clinical data for the LIBERTY System during its commercial launch [4] Market Positioning - The LIBERTY System is the first FDA-cleared single-use, remotely operated robotic system for peripheral endovascular procedures, aiming to transform the field by reducing the need for traditional capital equipment and dedicated infrastructure [3][4] - The remote design of the LIBERTY System is expected to improve ergonomics and reduce physical strain on healthcare providers, potentially enhancing procedure efficiency and lowering costs [4][6] - The company will present its developments at the H.C. Wainwright Annual Investor Conference on September 9, 2025, to engage with investors and stakeholders [5]