Microbot Medical has received 510(k) clearance from the U.S. Food and Drug Administration for its LIBERTY endovascular robotic system, paving the way for commercialization in the U.S. by the end of 2025.

The LIBERTY system is billed as the first single-use, remotely operated robotic technology cleared by the FDA for peripheral endovascular procedures. According to the Hingham, Massachusetts-based company, the platform is designed to eliminate the need for large capital investments or dedicated surgical suites typically associated with robotics.

In its pivotal clinical trial, the system demonstrated 100% success in robotic navigation to the target site and no device-related adverse events. The study also reported a 92% reduction in physician radiation exposure. Microbot noted the system’s remote operation could help reduce ergonomic strain on interventionalists, with plans to continue clinical data collection during the initial commercial rollout.
"The FDA 510(k) clearance for LIBERTY marks a defining moment for Microbot Medical and, we believe, for the future of endovascular robotics," said Harel Gadot, the company’s chairman, CEO and president. "With FDA clearance, we can now complete the final commercial activities that were contingent on marketing clearance."

Microbot said its initial U.S. market opportunity includes approximately 2.5 million peripheral vascular procedures annually. The company has been working on its commercialization strategy since the second quarter of 2025 and expects to begin U.S. sales in the fourth quarter.

Gadot is scheduled to speak at the H.C. Wainwright Annual Investor Conference in New York on September 9. The presentation will be webcast via the company's website, and management will also be available for one-on-one meetings with investors.

Microbot trades on the Nasdaq under the ticker MBOT.

U.S. Healthcare Homepage