Microbot Medical has submitted a 510(k) premarket notification for its disposable endovascular robotic system, LIBERTY, to the US Food and Drug Administration (FDA) seeking approval for commercial launch.

In October, the company completed the multi-centre, single-arm, prospective ACCESS-PVI trial assessing the system’s safety and performance in humans undergoing peripheral vascular interventions. The submission follows the completion of this trial.

Clearance from the FDA is anticipated in the second quarter of next year, with US commercialisation to follow.

The LIBERTY system aims to revolutionise endovascular procedures by eliminating the need for costly capital equipment.

Its single-use design aims to enhance the quality of care while decreasing radiation exposure and physical strain on medical staff.

Microbot Medical chairman, CEO and president Harel Gadot said: “This is a pivotal milestone for our company, as the 510(k) submission reflects the commencement of our transition to a commercially focused company.

“We are excited to transition our focus towards preparing for our expected US launch in the second quarter of 2025 and targeting the more than two million peripheral vascular procedures performed in the US each year.

“We believe, based on feedback from physicians and the medical community, that LIBERTY is positioned to redefine the peripheral endovascular space with the introduction of the world’s first commercially available single-use robotic system.”

The company entered a Phase II collaboration with Corewell Health in August to further develop remote telesurgery capabilities.

This followed positive Phase I results demonstrating LIBERTY's technical potential for various endovascular interventions. The partnership aimed to perform simulated cardiovascular interventional procedures across two Corewell Health sites.

In the same month, the company and Emory University agreed to explore the system’s future autonomous capabilities.