Microbot Medical Wins FDA Clearance for LIBERTY Endovascular Robotic System

Microbot Medical has received FDA 510(k) clearance for its LIBERTY® Endovascular Robotic System, marking it as the first FDA-cleared single-use, remotely operated robotic system for peripheral endovascular procedures. This clearance enables Microbot to begin commercialization efforts in the U.S., targeting approximately 2.5 million peripheral vascular procedures annually. The LIBERTY system, designed to democratize access to advanced robotic technology, demonstrated 100% success in navigation and zero device-related adverse events in pivotal studies, while reducing physician radiation exposure by 92%. Its remote operation is also expected to improve ergonomics and reduce physical strain on healthcare providers. CEO Harel Gadot emphasized that this milestone validates the company's mission to expand advanced robotic access while supporting cost-effective healthcare and positions Microbot for accelerated market entry and global expansion. The company has been preparing its commercial readiness strategy since mid-2025 to capitalize on this FDA clearance.