Microbot Medical recently announced that it has submitted a 510(k) premarket notification to the Food and Drug Administration (FDA) for its Liberty endovascular robotic system.
A press release details that Liberty is the world’s first single-use, fully disposable robotic system for endovascular procedures. The 510(k) submission follows the successful completion of Microbot Medical’s multicenter, single-arm trial to evaluate the performance and safety of Liberty in human subjects undergoing peripheral vascular interventions.
The company anticipates FDA marketing clearance during the second quarter of 2025, with U.S. commercialization activities expected to commence after the clearance.
Microbot Medical states that Liberty eliminates the need for large and expensive capital equipment and streamlines customers’ access to robotics. With its remote control, Liberty is designed to significantly reduce radiation exposure to physicians and staff, and improve ergonomics, which has the potential to reduce the physical strain on healthcare providers. The company also believes that Liberty has the potential to lower procedure costs, increase procedure efficiency and improve the overall quality of care.
