Microbot Medical Inc. (Nasdaq: MBOT) has cleared a major commercial milestone: Israels Ministry of Health AMAR Division has granted marketing approval for the companys LIBERTY endovascular robotic system, making Israel the second jurisdiction worldwide and the first outside the United States to clear LIBERTY for commercial use.
What LIBERTY Is
LIBERTY is the only FDA-cleared single-use, remotely operated robotic platform for peripheral endovascular procedures. It is designed for precise vascular navigation while reducing both patient radiation exposure and the physical strain on interventionalists who stand under lead aprons in todays cath labs.
Why The AMAR Clearance Matters
The AMAR approval gives Microbot the right to commercialize LIBERTY in Israel and, via a Free Sale Certificate, supports regulatory submissions in additional jurisdictions. Chairman, CEO and President Harel Gadot said the company is already in advanced discussions to expedite the in-country commercial roll-out: We are continuing to execute on our growth strategies and making meaningful progress toward our overall commercial objectives, he said.
CE Mark Next On The Roadmap
Microbot is now working toward CE Mark certification by end-2026, which would open up the European Union, the worlds largest single endovascular market outside the US. The Israeli clearance also functions as a regulatory dress rehearsal, with the company arguing that the AMAR experience helps de-risk further submissions.
A Crowded Surgical Robotics Year
The clearance lands in a banner year for surgical robotics regulation. CMR Surgicals Versius Plus just won 510(k) clearance and is launching commercially in the US, Johnson & Johnson is expected to submit its Ottava platform, and a wave of capital is moving into the category alongside broader physical AI investment such as morphs new soft robotics platform. Microbot is differentiating with disposability and lower per-procedure cost, betting that the cath-lab economics not just the robot will decide market share.
Reporting based on coverage from Vascular News, GlobeNewswire and Microbot Medicals investor release.