Microbot Medical Submits 510(k) for Liberty Surgical Robot to FDA

Microbot Medical has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its Liberty endovascular robotic system.

According to the company, Liberty is the first single-use, fully disposable robotic system for endovascular procedures. It removes the need for large, expensive capital equipment, streamlining access to robotics.

Liberty’s remote control was designed to reduce radiation exposure to physicians and staff, as well as improve ergonomics. Microbot believes that Liberty could also lower procedure costs, increase procedural efficiency, and improve overall quality of care.

This 510(k) submission follows successful completion of its multi-center, single-arm trial to evaluate Liberty’s safety and performance in people undergoing peripheral vascular procedures.

Microbot expects FDA marketing clearance for Liberty during Q2 2025. The company will begin U.S. commercialization activities after the clearance is achieved. Chairman, president, and CEO Harel Gadot said the 510(k) submission is a pivotal milestone for the company and reflects its transition to a commercially focused company.

“We are excited to transition our focus towards preparing for our expected U.S. launch in the second quarter of 2025 and targeting the more than 2 million peripheral vascular procedures performed in the U.S. each year,” Gadot told the press. “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.”