Robotics company Microbot Medical Inc. (Nasdaq: MBOT) announced yesterday that the US Food and Drug Administration (FDA) had granted clearance on the 510(k) track (a regulatory procedure for approval of medical devices) for its Liberty endovascular robotic system. Following the announcement, the company’s share price jumped 22%, making it a 400% rise in the past year. The company currently has a market cap of $218 million. It is based in Yokne’am and Hingham, Massachusetts.
Microbot Medical describes its product as “intended for use in the remote delivery and manipulation of guidewires and catheters, and remote manipulation of guide catheters to facilitate navigation to anatomical targets in the peripheral vasculature.” It says that the system is the first FDA-cleared single-use, remotely operated robotic system for peripheral endovascular procedures. “The FDA clearance positions the company to commercialize Liberty in the US, with the goal of transforming the field to enable accessibility to advanced robotics without the traditional constraints of capital equipment and a dedicated infrastructure,” the company’s announcement states.
“Obtaining FDA 510(k) clearance for Liberty marks a defining moment for Microbot Medical and, we believe, for the future of endovascular robotics. This achievement validates our mission to expand access to advanced robotic technologies while addressing critical unmet needs and supporting cost-effective healthcare,” said Microbot Medical chairperson, CEO and president Harel Gadot.
Microbot Medical was merged into a stock market shell company in 2016, and since then it has known very low valuations and undergone many ATM offerings such as generally characterize a company in distress. But since mid-2024, when the company began human trials of its product, and subsequently announced that the trial was progressing faster than planned, in cooperation with leading hospitals, the market has begun to find renewed interest in it. In December 2024, the company announced that it was awaiting FDA clearance, which sparked the rally in its share price.
Published by Globes, Israel business news – en.globes.co.il – on September 9, 2025.
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