Microbot Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its LIBERTY Endovascular Robotic System.
Designed for peripheral endovascular procedures, LIBERTY is said to be the first FDA-approved single-use, remotely operated robotic device.
In the clinical study, the LIBERTY System showed successful robotic navigation in all cases with no device-related adverse events.
The system achieved a 92% reduction in radiation exposure for physicians.
Its remote-control design is expected to enhance ergonomics and reduce physical strain on healthcare providers, lowering procedure costs and enhancing care quality.
The US-based medical device company plans to start commercialising the system in the US during Q4 2025.
Microbot Medical chairman, CEO and president Harel Gadot said: “This achievement validates our mission to expand access to advanced robotic technologies while addressing critical unmet needs and supporting cost-effective healthcare.
“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.”
According to Microbot Medical, the LIBERTY System offers a new approach to endovascular procedures with remote manipulation of guidewires and catheters.
The system aims to improve precision and safety without the need for significant capital investment.
Building on its compact, single-use system, LIBERTY integrates easily into existing workflows and requires no additional infrastructure. Also, the system enables swift setup and universal compatibility with preferred instruments, said Microbot Medical.
