Microbot Medical Secures Marketing Clearance in Israel, Enables Free Sale Certificate
MBOT•Microbot Medical secured marketing clearance from Israel’s Ministry of Health for its LIBERTY Endovascular Robotic System, marking the first approval outside the U.S. This clearance grants a Free Sale Certificate for additional jurisdictions and the company targets CE Mark certification by end-2026 ahead of EU expansion.
1. Regulatory Clearance in Israel
Microbot Medical achieved marketing clearance from the Israeli Ministry of Health’s AMAR Division for its LIBERTY Endovascular Robotic System, marking the first approval outside the United States and designating Israel as the second jurisdiction to authorize commercial sales.
2. Free Sale Certificate and International Submissions
The AMAR approval allows the company to obtain a Free Sale Certificate, facilitating regulatory submissions and commercial activities in additional markets while reinforcing the company’s strategy for global expansion.
3. EU Market Pathway
Microbot Medical is targeting CE Mark certification by the end of 2026 to enable entry into the European Union market, aligning with its phased international launch strategy.
4. U.S. Commercial Traction
Since its U.S. launch, multiple hospitals in Georgia, Florida, New York, Massachusetts, Michigan and North Carolina have adopted the LIBERTY System, demonstrating initial market acceptance and clinical integration across key states.
