Microbot Medical receives first international approval for robotic system

Microbot Medical Inc. (NASDAQ: MBOT) received regulatory approval from Israel's Ministry of Health to market its LIBERTY Endovascular Robotic System, marking the first international clearance for the device outside the United States.

The approval from the AMAR Division allows the company to commercialize the robotic system in Israel and obtain a Free Sale Certificate to support regulatory submissions in additional markets. Microbot continues pursuing CE Mark certification with completion targeted by the end of 2026 for European Union market entry.

The LIBERTY system received FDA clearance and has been adopted by hospitals across six U.S. states including Georgia, Florida, New York, Massachusetts, Michigan, and North Carolina. The device is designed as a single-use, remotely operated robotic system for peripheral endovascular procedures.

"This is an important regulatory milestone for the LIBERTY System and demonstrates that, as a Company, we are continuing to execute on our growth strategies," said Harel Gadot, Chairman, CEO and President. The company is in discussions to expedite commercialization in Israel while leveraging the approval for additional markets.

The robotic system aims to provide precise vascular navigation while reducing radiation exposure and physical strain during procedures. Microbot Medical develops and distributes the technology for endovascular procedures through advanced robotic solutions.

Information is based on a company press release statement.

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