Microbot Medical announced today that it has achieved a regulatory milestone as Israel becomes the second jurisdiction—and first outside of the USA—to grant marketing clearance for the company’s Liberty endovascular robotic system.
A press release details that regulatory approval from the Israeli Ministry of Health’s AMAR Division, the authority responsible for medical device regulation in Israel, allows Microbot Medical to market and commercialise the Liberty system in Israel. It also enables the company to obtain a Free Sale Certificate to support submissions and commercial activities in additional jurisdictions.
Microbot Medical notes that it 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 launch of the Liberty system in the USA, which continues to be the focused territory for the company.
“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 commercialisation efforts in Israel, and we are already in advanced discussions to expedite the commercialisation process and accelerate the adoption of the system there, while leveraging this approval and experience to pursue additional relevant markets.”
Microbot Medical advises that Liberty is the only US Food and Drug Administration (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.
