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Microbot’s Liberty Robotic System Gains FDA Clearance

Robotics

Business Honor
09 September, 2025

Microbot’s Liberty system receives FDA clearance, allowing the U.S. launch of the remotely operated, disposable, and safe endovascular robotic device.

The Liberty® Robotic System received Microbot Medical 510(k) clearance from the U.S. Food and Drug Administration (FDA). Clearing the path for commercial launch in the United States as the first FDA-approved, single-use, remotely operated robotic device for peripheral endovascular operations. Liberty is small, disposable, and designed to be more easily used in healthcare institutions than standard robotic systems, that call for specific spaces and huge, costly equipment. Its remote-controlled design improves access to robotic treatments, safety, and performance.

The second quarter of 2025 marks the beginning of the company's commercial activities. As that regulatory approval has been obtained, Microbot will be completing the last steps for its U.S. market launch. Liberty will reach foreign markets and aims to provide approximately 2.5 million peripheral vascular treatments across the nation each year.

Liberty showed the success in robotic navigation up to the goal and no negative device events in the clinical study. Resulted in a 92% decrease in exposure to radiation for doctors, offering a safety benefit. In addition to increasing treatment times and reducing expenses, the system’s design is expected to improve doctor comfort that reduces physical strain during treatments.

CEO, chairman, and the president of Microbot Medical, Harel Gadot, stated, "This is an important development for Microbot and for the future of endovascular robotics." "With the FDA approval, we're getting closer to serving more patients with modern robotics with affordable care." As Liberty launches, Microbot Medical continues to gather clinical data with an aim to ease larger adoption and show its lasting benefits.