Microbot Medical Unveils Groundbreaking Surgical Robot Amid Fda Approval Push

Microbot Medical Inc. has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its innovative LIBERTY surgical robot, designed to transform the field of peripheral vascular procedures. The company anticipates FDA clearance during the second quarter of 2025.

The company’s Chairman, CEO, and President, Harel Gadot, expressed excitement about this development, stating that the 510(k) submission represents the commencement of the company’s shift towards commercialization. “We’re poised to make a profound impact on the healthcare industry with Liberty, which is poised to redefine the peripheral endovascular space,” Gadot said.

LIBERTY, a single-use, fully disposable robotic system, eliminates the need for costly capital equipment and streamlines access to robotics for medical professionals. By incorporating a remote control, Microbot Medical has significantly reduced radiation exposure to physicians and staff, while also enhancing ergonomics. This innovative design is expected to reduce physical strain on healthcare providers, leading to improved working conditions.

The LIBERTY system is designed to be compact, remote-operated, and versatile, making it suitable for neurovascular, cardiovascular, and peripheral vascular procedures. Its potential benefits include lower procedure costs, increased efficiency, and enhanced overall quality of care.

A successful multi-center, single-arm trial evaluating the performance and safety of LIBERTY in human subjects undergoing peripheral vascular interventions has been completed at Brigham and Women’s Hospital (BWH) in Boston. Microbot Medical has also secured a $2.154 million settlement of a lawsuit involving a securities purchase agreement in January as part of its expanded U.S. operations ahead of an upcoming IDE submission.

The company is preparing for commercial launch in the second quarter of 2025, with robust pre-clinical study results and positive feedback from medical professionals supporting the system’s potential to revolutionize the field of peripheral vascular procedures. By providing a more efficient, cost-effective, and patient-centric approach, Microbot Medical is poised to redefine the standard of care for millions of patients worldwide.