Microbot Medical Inc, an innovative medical technology firm still in the pre-commercial phase, is dedicated to enhancing patient and provider care on a global scale. The company has developed the pioneering LIBERTY, a single-use endovascular robotic system, and has now shared that it has filed a 510(k) pre-market notification with the US Food and Drug Administration (FDA) for its LIBERTY system.
LIBERTY stands out as the world’s first fully disposable robotic system designed specifically for endovascular procedures. The 510(k) notification follows the successful wrap-up of a multi-center, single-arm clinical study assessing the system’s efficacy and safety in patients undergoing peripheral vascular treatments.
The company foresees FDA clearance for US marketing during Q2 of 2025, with plans for commercialization in the US set to follow post-clearance.
“Achieving this 510(k) milestone is crucial for us, as it signifies our shift towards a more commercially driven organization,” stated Harel Gadot, who serves as chairman, CEO, and President. “We eagerly anticipate concentrating on preparations for our expected US launch in the second quarter of 2025. We aim to serve a market that conducts over 2 million peripheral vascular procedures annually in the US. Feedback from medical professionals and the broader community indicates that LIBERTY is poised to transform the peripheral endovascular sector by being the first single-use robotic system available commercially.”
As the solitary fully disposable robotic solution for endovascular operations, LIBERTY eliminates the requirement for substantial and costly equipment while simplifying access to robotic technologies for healthcare facilities. With its remote capabilities, LIBERTY aims to significantly decrease radiation exposure for practitioners and staff, enhance ergonomic comfort, and potentially alleviate physical stress on healthcare workers. The system is also projected to reduce procedural expenses, boost efficiency, and elevate the standard of care provided.