Microbot Medical today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the Liberty system, the first FDA cleared single use, remotely operated robotic system for peripheral endovascular procedures, states the company in a recent press release.
The FDA clearance positions the company to commercialise Liberty in the US, with the goal of transforming the field to enable accessibility to advanced robotics without the traditional constraints of capital equipment and a dedicated infrastructure.
“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, chairman, chief executive officer and president of Microbot Medical.
“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 commercialisation, penetrate the approximately 2.5 million annual US peripheral vascular procedures, and pursue entry into global markets.”
The Liberty pivotal study showed 100% success in the robotic navigation to target, and zero device related adverse events. The study also showed a 92% relative reduction in radiation exposure for physicians. Its remote design is expected to improve ergonomics, which would aid in reducing the physical strain on healthcare providers. The company believes that Liberty has the potential to enhance procedure efficiency, lower procedure costs, and improve the overall quality of care. The company plans to continue clinical data collection for Liberty during the commercial launch.
