Microbot Medical® Announces International Regulatory Approval for the Commercialisation of the LIBERTY® Endovascular Robotic System

Microbot Medical Inc. has announced that it has achieved a significant regulatory milestone as Israel becomes the second jurisdiction, and the first outside of the U.S., to grant marketing clearance for the LIBERTY System. The regulatory approval from the Israeli Ministry of Health’s AMAR Division, the authority responsible for medical device regulation in Israel, allows the Company to market and commercialize the LIBERTY System in Israel, which also enables the company to obtain a Free Sale Certificate to support submissions and commercial activities in additional jurisdictions. The Company continues to pursue CE Mark certification and is working toward completion by the end of 2026, in preparation for the next phase of commercial expansion into the EU market.

The expansion into international markets follows the successful launch of the LIBERTY System in the U.S. , which continues to be the focused territory for the Company. Multiple accounts and hospitals in Georgia, Florida, New York, Massachusetts, Michigan, and North Carolina have already adopted the LIBERTY System.

“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 and making meaningful progress toward our overall commercial objectives,” commented Harel Gadot, Chairman, CEO and President. “The AMAR approval gives us marketing clearance and supports commercialization efforts in Israel, and we are already in advanced discussions to expedite the commercialization process and accelerate the adoption of the system there, while leveraging this approval and experience to pursue additional relevant markets.”

LIBERTY is the only FDA-cleared, single-use, remotely operated robotic system for peripheral endovascular procedures, and it is designed for precise vascular navigation while aiming to reduce radiation exposure and physical strain.

Source:  Microbot Medical Inc.
 

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