Microbot Medical Inc. announced on September 8, 2025, that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its LIBERTY Endovascular Robotic System. This marks a defining moment for the company, as LIBERTY is the first FDA-cleared single-use, remotely operated robotic system for peripheral endovascular procedures.
This FDA clearance positions Microbot Medical to commercialize LIBERTY in the U.S., with the goal of transforming the field by enabling accessibility to advanced robotics without the traditional constraints of capital equipment and dedicated infrastructure. The company aims to penetrate the approximately 2.5 million annual U.S. peripheral vascular procedures.
The LIBERTY pivotal study demonstrated 100% success in robotic navigation to target and reported zero device-related adverse events. The study also showed a 92% relative reduction in radiation exposure for physicians, highlighting the system's safety and efficacy. Commercialization is expected to commence during Q4 2025.
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