Microbot Medical (Nasdaq: MBOT) disclosed today its filing of an FDA 510(k) premarket notification for the Liberty surgical robot. This unique device is tailored for use in fields such as neurovascular, cardiovascular, and peripheral vascular surgery.
The Liberty system is designed with a compact framework and offers remote operation to minimize both radiation exposure and physical fatigue for medical professionals. Positioned in Braintree, Massachusetts, Microbot aims for Liberty’s remote capabilities to be groundbreaking in making endovascular interventions more accessible. Notably, it is claimed to be the first-ever fully disposable, single-use robotic system worldwide for such procedures.
The FDA submission from Microbot was made after concluding a recent study on human patients undergoing peripheral vascular treatment. The company anticipates receiving clearance by the second quarter of 2025, marking the beginning of U.S. market entry. As part of these efforts, plans have been outlined for marketing strategies, including the recruitment of a healthcare industry leader to spearhead sales initiatives.
Harel Gadot, the chair, CEO, and president of Microbot, expressed that this FDA submission represents a major step in transitioning the firm to a company focused on commercial activities. “We are eager to concentrate our efforts towards launching in the U.S. next year,” Gadot stated. “Feedback from the medical community suggests Liberty could transform the market by introducing the leading single-use robot for vascular procedures.”