Microbot Medical (Nasdaq:MBOT) announced today that it received FDA 510(k) clearance for its Liberty endovascular surgical robot.
Clearance makes Liberty the first FDA-cleared single-use, remotely operated robotic system for peripheral endovascular procedures. Microbot can now begin U.S. commercialization efforts to advance robotics without the constraints of capital equipment and a dedicated infrastructure.
Hingham, Massachusetts-based Microbot designed the Liberty robot to democratize endovascular interventional procedures. The company says it’s the world’s first single-use, fully disposable robotic system for those procedures. The company submitted Liberty to the FDA in December 2024.
Data from the LIBERTY pivotal study supported the submission. Findings included 100% success in the robotic navigation to target and zero device-related adverse events. Microbot’s remote design could improve ergonomics, reducing the physical strain on healthcare providers.
The company previously said it expected to launch Liberty during the third quarter of 2025. Chair, CEO and President Harel Gadot said its commercial readiness strategy positions Microbot to accelerate market entry.
“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,” commented Harel Gadot, chair, CEO & president. “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.”
