The US Food and Drug Administration (FDA) has cleared Microbot’s LIBERTY, a single-use, remotely operated robotic system for peripheral endovascular procedures.

Microbot completed the ACCESS-BVI pivotal trial (NCT06141694) for its system in April 2025. Meeting the primary and secondary endpoints, the study demonstrated a 100% success rate in the robotic navigation to target with zero device-related adverse events (AEs) through the three-day follow-up period.

Microbot’s chairman and CEO Harel Gadot revealed that the company has been developing its ‘commercial readiness’ strategy since Q2 2025 and is now ‘well-positioned’ to accelerate its market entry.