FDA clears single-use, fully disposable endovascular robotic system
Microbot Medical, a medical device company with offices in the United States and Israel, has received clearance from the U.S. Food and Drug Administration (FDA) for its Liberty Endovascular Robotic System.
According to Microbot Medical, Liberty is the first robotic system of its kind to gain FDA clearance. The single-use, fully-disposable technology allows users to remotely deliver and manipulate guidewires and catheters during peripheral endovascular procedures. It can be fully set up in less than five minutes, and its compact design means it can be easily implemented into preexisting workflows.
“Obtaining FDA 510(k) clearance for Liberty marks a defining moment for Microbot Medical and, we believe, for the future of endovascular robotics,” Harel Gadot, chairman, CEO and president of Microbot Medical, said in a statement. “This achievement validates our mission to expand access to advanced robotic technologies while addressing critical unmet needs and supporting cost-effective healthcare. With our commercial readiness strategy being developed and executed since Q2 this year, we believe we are well positioned to accelerate market entry. With FDA clearance, we can now complete the final commercial activities that were contingent on marketing clearance, positioning us to commence commercialization, penetrate the approximately 2.5 million annual U.S. peripheral vascular procedures, and pursue entry into global markets.”
The FDA’s decision was based in part on data from the Liberty pivotal study, which linked the technology to a success rate of 100% and no device-related adverse events. In addition, researchers reported a relative reduction in radiation exposure to clinicians of 92%.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.