Microbot’s Liberty Endovascular Robotic System Submitted for FDA Clearance

December 10, 2024—Microbot Medical Inc. announced that it has submitted a 510(k) premarket notification to the FDA for the Liberty endovascular robotic system.

According to Microbot, the 510(k) submission comes after the completion of its multicenter, single-arm trial to evaluate the performance and safety of Liberty in human patients undergoing peripheral vascular interventions.

In October 2024, the company announced the completion of enrollment and follow-up for all patients in the prospective ACCESS-PVI clinical trial of the Liberty endovascular robotic surgical system.

The company stated that it anticipates FDA marketing clearance during the second quarter of 2025; after that, it will begin commercialization in the United States.

As noted in the press release, Liberty is a single-use, fully disposable robotic system for endovascular procedures. It is intended to eliminate the need for large and expensive capital equipment and streamlines customers’ access to robotics. It is designed to be operated with its remote control to significantly reduce radiation exposure to physicians and staff and to improve ergonomics. The Liberty system has the potential to lower procedure costs, increase procedure efficiency, and improve the overall quality of care, noted the company.