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Liberty's pivotal study showed 100% success in the robotic navigation to target, and no device-related adverse events.
September 8, 2025
By: Sam Brusco
Associate Editor
Microbot Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Liberty endovascular robotic system, a single-use, remotely operated robotic system for peripheral endovascular procedures.
The FDA nod positions Microbot to commercialize Liberty in the U.S. The company hopes to transform the field and allow accessibility to advanced robotics without the traditional constraints of capital equipment and a dedicated infrastructure.
Liberty’s pivotal study showed 100% success in the robotic navigation to target, and no device-related adverse events. The study also demonstrated 92% relative reduction in radiation exposure for physicians.
Its remote design aims to improve ergonomics, which can help reduce the physical strain on healthcare providers. The company believes Liberty could enhance procedure efficiency, lower procedure costs, and improve quality of care. It plans to continue clinical data collection for Liberty during commercial launch.
“Obtaining FDA 510(k) clearance for LIBERTY marks a defining moment for Microbot Medical and, we believe, for the future of endovascular robotics. This achievement validates our mission to expand access to advanced robotic technologies while addressing critical unmet needs and supporting cost-effective healthcare,” said Harel Gadot, Microbot Medical’s Chairman, CEO, and President. “With our commercial readiness strategy being developed and executed since Q2 this year, we believe we are well positioned to accelerate market entry. With FDA clearance, we can now complete the final commercial activities that were contingent on marketing clearance, positioning us to commence commercialization, penetrate the approximately 2.5 million annual U.S. peripheral vascular procedures, and pursue entry into global markets.”
Last week, the company announced it had received a non-dilutive NIS 2.15 million ($630,000) grant from the Israel Innovation Authority (IIA) to further strengthen its manufacturing capabilities and position the company to commercialize LIBERTY.
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