Microbot Medical Secures FDA Clearance for Endovascular Robotic System

What's Happening?

Microbot Medical has received 510(k) clearance from the Food and Drug Administration for its Liberty Endovascular Robotic System. This clearance allows the company to market its single-use, remotely operated robotic system designed for peripheral endovascular procedures. The Liberty system features a video game-style controller that enables physicians to guide instruments through blood vessels remotely, aiming to reduce radiation exposure and physical strain. Microbot has reported successful trial results, including a 92% reduction in radiation exposure and 100% success in robotic navigation without device-related adverse events. The company plans to complete final commercial activities to penetrate the U.S. market, targeting approximately 2.5 million annual peripheral vascular procedures.

Why It's Important?

The FDA clearance is a significant milestone for Microbot Medical, positioning the company to enter the competitive market of robotic-assisted medical procedures. This development could impact the healthcare industry by offering a new solution that reduces radiation exposure and simplifies surgical procedures. The Liberty system's design may also lower costs by eliminating the need for expensive surgical tools and dedicated cath-lab rooms. As Microbot prepares to commercialize its product, it could challenge existing players and potentially lead to advancements in robotic medical technology.

What's Next?

Microbot Medical plans to finalize commercial activities contingent on the FDA clearance, aiming to commence commercialization in the U.S. and pursue entry into global markets. The company has secured additional funding to strengthen its manufacturing capabilities, supporting the Liberty system's rollout. As Microbot enters a market previously explored by Siemens Healthineers, it may face competition from other companies developing similar technologies. The success of the Liberty system could influence future innovations in robotic-assisted medical procedures.