Microbot Medical Expands Global Reach as Israel Grants Marketing Approval for LIBERTY Endovascular Robotic System
Microbot Medica a commercial-stage medical device company focused on advancing robotic technologies for endovascular procedures, has achieved a major regulatory milestone with the approval of its LIBERTY® Endovascular Robotic System in Israel. The authorization, granted by the Israeli Ministry of Health’s AMAR Division, marks the company’s first international regulatory clearance outside the United States and represents a significant step in its global commercialization strategy.
The approval enables Microbot Medical to market and commercialize the LIBERTY System in Israel, while also creating opportunities for broader international expansion. Importantly, the regulatory clearance allows the company to obtain a Free Sale Certificate, a critical document that supports regulatory submissions and commercial activities in additional international markets. The milestone strengthens the company’s position as it continues to pursue regulatory approvals across multiple regions and expand the global footprint of its innovative robotic platform.
Strategic Expansion Beyond the U.S. Market
The Israeli approval arrives as Microbot Medical continues to build momentum following the successful commercial launch of the LIBERTY System in the United States. While the U.S. remains the company’s primary market and strategic focus, leadership views international expansion as a key component of its long-term growth plans.
Since receiving U.S. regulatory clearance, the LIBERTY System has been adopted by a growing number of hospitals and healthcare facilities across several states, including Georgia, Florida, New York, Massachusetts, Michigan, and North Carolina. These installations demonstrate increasing interest in robotic-assisted endovascular technologies and reflect healthcare providers’ desire for solutions that can improve procedural precision while enhancing physician ergonomics and workflow efficiency.
By securing approval in Israel, Microbot Medical is laying the groundwork for broader commercialization efforts across global healthcare markets. The company believes that the approval will not only facilitate direct market entry into Israel but also serve as a valuable regulatory reference point for future submissions in other countries.
AMAR Approval Represents a Significant Regulatory Achievement
The Israeli Ministry of Health’s AMAR Division serves as the country’s regulatory authority for medical devices, overseeing product evaluation, safety assessments, and market authorizations. Receiving approval from this organization demonstrates that the LIBERTY System has met applicable regulatory requirements for commercialization within Israel.
For Microbot Medical, the achievement extends beyond access to a single market. The ability to obtain a Free Sale Certificate following the approval is particularly important because many international regulatory agencies require such documentation as part of their own evaluation processes. This certificate verifies that the device is legally marketed in an approved jurisdiction and can help streamline entry into additional countries.
As healthcare technology companies seek to expand internationally, obtaining regulatory approvals in strategically important markets often serves as a catalyst for future growth. Microbot Medical expects the Israeli authorization to support its broader global expansion initiatives and strengthen its position in discussions with regulators, healthcare providers, and potential commercial partners worldwide.
Preparing for Entry into European Markets
Alongside its commercialization efforts in Israel, Microbot Medical continues to pursue CE Mark certification for the LIBERTY System. Achieving CE Mark approval remains one of the company’s primary regulatory objectives as it works toward entering European Union markets.
The company has indicated that it is progressing toward completion of the CE Mark process by the end of 2026. Successful certification would allow the LIBERTY System to be marketed across numerous European countries, significantly expanding its potential customer base and opening new opportunities for growth.
Europe represents one of the largest medical device markets globally, with increasing demand for innovative technologies that improve procedural outcomes, operational efficiency, and clinician safety. By pursuing CE Mark certification, Microbot Medical aims to position itself to capitalize on these trends while establishing a stronger international presence.
Leadership Highlights Commercial Momentum
According to company leadership, the AMAR approval reflects continued progress toward executing strategic growth initiatives and advancing commercialization goals.
Harel Gadot, Chairman, Chief Executive Officer, and President of Microbot Medical, emphasized the importance of the regulatory milestone and its role in supporting future expansion efforts.
The approval provides the company with marketing clearance in Israel and creates a pathway toward accelerating commercialization activities within the region. Company executives have indicated that discussions are already underway with potential partners and stakeholders to facilitate adoption of the LIBERTY System in the Israeli healthcare market.
Management also views the approval as an opportunity to leverage regulatory and commercial experience gained in Israel as the company pursues additional international markets. The knowledge obtained through the approval process and early commercialization efforts may help support future market-entry strategies and regulatory submissions elsewhere.
Advancing Robotic Innovation in Endovascular Care
The LIBERTY Endovascular Robotic System is designed to transform the way endovascular procedures are performed by enabling physicians to remotely navigate devices within the vascular system. The platform combines robotic technology with a single-use design intended to enhance precision, improve workflow efficiency, and support procedural safety.
A key differentiator of the LIBERTY System is its status as the only FDA-cleared, single-use, remotely operated robotic system for peripheral endovascular procedures. The technology allows physicians to control catheter-based devices remotely, potentially reducing exposure to radiation while minimizing the physical strain associated with performing lengthy procedures in protective lead aprons.
Endovascular interventions are commonly used to diagnose and treat vascular conditions through minimally invasive techniques. As procedural complexity continues to increase, healthcare providers are increasingly exploring technologies that can improve navigation accuracy while reducing occupational challenges faced by clinicians.
Microbot Medical believes that robotic-assisted solutions have the potential to play a growing role in the future of vascular care by offering enhanced control, precision, and consistency during procedures. The company continues to invest in product development and commercialization efforts aimed at expanding access to robotic endovascular technologies.
Growing Demand for Robotic-Assisted Procedures
The broader healthcare industry has witnessed significant growth in the adoption of robotic technologies across multiple medical specialties. From surgical robotics to image-guided interventions, healthcare providers are increasingly incorporating advanced technologies designed to improve patient outcomes and procedural efficiency.
In the field of endovascular medicine, robotic systems are attracting attention for their ability to support precise device manipulation while potentially reducing physician fatigue and radiation exposure. These advantages may become increasingly important as healthcare systems seek solutions that improve both patient care and clinician well-being.
Microbot Medical’s single-use robotic platform also aligns with industry trends emphasizing simplified workflows, operational efficiency, and infection-control considerations. By eliminating the need for reusable robotic components, the company aims to provide healthcare facilities with a streamlined approach to robotic-assisted interventions.
Positioning for Long-Term Growth
As Microbot Medical advances its commercialization strategy, the company remains focused on expanding adoption of the LIBERTY System while pursuing additional regulatory approvals. The combination of growing U.S. adoption, newly secured international authorization, and ongoing CE Mark efforts positions the organization for continued expansion over the coming years.
The Israeli approval represents more than a regulatory achievement; it signals the beginning of a broader international growth phase for the company. With increasing interest in robotic-assisted endovascular procedures and continued investment in innovative medical technologies worldwide, Microbot Medical is seeking to establish the LIBERTY System as a differentiated solution within the evolving vascular intervention landscape.
As healthcare providers continue to adopt advanced technologies designed to improve precision, efficiency, and safety, Microbot Medical’s latest regulatory success underscores the company’s commitment to expanding access to robotic endovascular care and advancing the future of minimally invasive vascular treatme
About Microbot Medical
Microbot Medical Inc. (NASDAQ: MBOT) is a commercial stage medical device company focused on transforming endovascular procedures through advanced robotic technology. Microbot’s LIBERTY® Endovascular Robotic System is the first single-use, remotely operated robotic solution designed for precision, efficiency and safety. Backed by a strong intellectual property portfolio and a commitment to innovation, Microbot is driving the future of endovascular care.
