FDA Clears Microbot Medical’s LIBERTY® Endovascular Robotic System: A New Era in Vascular Intervention

September 2025 – Washington, D.C. — The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Microbot Medical’s LIBERTY® Endovascular Robotic System, making it the first fully disposable, remotely operated robotic system authorized for peripheral vascular procedures. This landmark decision marks a major milestone for both the company and the broader field of interventional medicine, setting the stage for new standards in safety, efficiency, and accessibility within endovascular care.

A Groundbreaking First for Robotic Surgery

Unlike traditional robotic platforms that require significant infrastructure, large footprints, and high upfront investment, the LIBERTY® system is single-use, portable, and fully disposable. Designed to integrate seamlessly into existing catheterization labs and interventional suites, it eliminates many barriers that hospitals face when adopting robotic systems.

The clearance positions LIBERTY® as the first-of-its-kind endovascular robotic device to be approved for use in the U.S., targeting a market of nearly 2.5 million annual peripheral vascular interventions. These procedures, which include treatments for blocked arteries, aneurysms, and other vascular complications, are essential to reducing morbidity and mortality in patients with cardiovascular disease — the leading cause of death in the United States.

Clinical Validation: ACCESS-PVI Trial Results

FDA’s decision was supported by robust evidence from the pivotal ACCESS-PVI trial, a multicenter study designed to evaluate the safety and effectiveness of LIBERTY®.

Key outcomes include:

• 100% success rate in robotic navigation to the target lesion.

• Zero device-related serious adverse events reported during the study.

• 92% reduction in operator radiation exposure, compared to conventional techniques.

• Average navigation time of just three minutes to reach treatment targets.

• Full satisfaction among participating interventional physicians.

These findings were presented earlier this year at the Society of Interventional Radiology (SIR) 2025 annual meeting in Nashville, Tennessee, drawing significant attention from vascular surgeons, interventional radiologists, and hospital administrators seeking safer and more efficient procedural tools.

Dr. Joseph Walter, an interventional radiologist who participated in the trial, stated:

“LIBERTY achieved consistent, reliable navigation in every case. The reduction in radiation exposure for operators is particularly impressive — it represents a leap forward for both patient and physician safety.”

Addressing Longstanding Challenges in the Cath Lab

Traditional endovascular interventions expose physicians and staff to high levels of radiation and physical strain due to the need for prolonged use of lead aprons and repetitive manual movements. Over time, these occupational hazards contribute to musculoskeletal injuries, fatigue, and increased risk of cancer.

LIBERTY® directly addresses these challenges by enabling remote operation. Physicians can control the system from outside the immediate radiation field, reducing exposure while maintaining precision in navigation and device deployment.

The device’s disposable design also eliminates concerns about sterilization, cross-contamination, and costly maintenance associated with reusable robotic systems. According to Microbot Medical, this innovation not only enhances patient safety but also lowers long-term hospital costs, making robotic intervention more financially feasible for a wider range of facilities, including smaller community hospitals.

Implications for Hospitals and Healthcare Systems

The FDA’s clearance carries important implications for healthcare providers:

• Operational efficiency: Hospitals may shorten procedure times and reduce delays caused by equipment turnover or malfunctions.

• Cost management: Disposable systems could lower capital expenditures and simplify procurement processes.

• Patient access: By reducing complexity, more institutions may offer advanced robotic-assisted vascular procedures, improving access for patients in both urban and rural areas.

• Staff safety: Significant reductions in radiation exposure could change occupational health standards in interventional medicine.

Industry analysts estimate that the global market for robotic-assisted vascular procedures could grow at a double-digit annual rate through the next decade, with LIBERTY® positioned to capture a sizable share.

Following the FDA announcement, Microbot Medical’s leadership highlighted the transformative potential of the clearance. Harel Gadot, CEO of Microbot Medical, described the decision as a “defining moment” for the company, emphasizing its mission to democratize access to robotic intervention.

“LIBERTY is designed to overcome the limitations of traditional robotic systems. With FDA clearance, we are one step closer to changing how endovascular care is delivered, making it safer, more accessible, and more efficient for both patients and physicians,” Gadot said.

Medical device strategists point out that LIBERTY® also arrives at a time of growing demand for vascular interventions due to aging populations, higher prevalence of diabetes and peripheral artery disease, and increasing reliance on minimally invasive procedures. By combining portability with disposability, the system may appeal to hospitals under pressure to optimize both outcomes and costs.

Dr. Rachel Lopez, Director of Endovascular Services at a large U.S. health system, commented on the broader implications:

“For years, robotic platforms have promised precision and safety, but adoption was limited by cost and infrastructure. A disposable system changes that equation. We may finally see robotics integrated into everyday vascular care, not just at elite academic centers.”

Supply chain leaders also see potential disruption. With a single-use model, hospitals will need to adapt procurement strategies to manage higher volumes of consumables, while ensuring cost-efficiency through vendor contracts and bulk purchasing.

With clearance in hand, Microbot Medical is preparing for U.S. commercialization. The company is expected to launch pilot programs in select hospitals later this year, followed by a broader rollout in 2026. Key areas of focus will include:

• Training and education: Ensuring physicians and staff are trained on safe and effective use of the system.

• Supply chain scaling: Expanding manufacturing capacity to meet anticipated demand.

• Global expansion: Pursuing regulatory approval in Europe and other international markets.

Longer term, Microbot plans to adapt LIBERTY® for additional endovascular applications beyond peripheral interventions, potentially expanding into neurovascular and coronary procedures.