Microbot Medical secures FDA clearance for endovascular surgical robot

While over 5 million endovascular procedures are performed in the U.S. each year, Microbot says less than 1% are done robotically. | Source: Microbot Medical

Microbot Medical today announced its Liberty endovascular surgical robot earned 510(k) clearance from the U.S. Food and Drug Administration (FDA). The company claimed this makes Liberty the first FDA-cleared single-use, remotely operated robotic system for peripheral endovascular procedures.

“Obtaining FDA 510(k) clearance for Liberty marks a defining moment for Microbot Medical and, we believe, for the future of endovascular robotics. This achievement validates our mission to expand access to advanced robotic technologies while addressing critical unmet needs and supporting cost-effective healthcare,” Harel Gadot, chairman, CEO, and president of Microbot Medical, said.

“With our commercial readiness strategy being developed and executed since Q2 this year, we believe we are well-positioned to accelerate market entry. With FDA clearance, we can now complete the final commercial activities that were contingent on marketing clearance, positioning us to commence commercialization, penetrate the approximately 2.5 million annual U.S. peripheral vascular procedures, and pursue entry into global markets,” he continued.

The FDA clearance positions the company to commercialize Liberty in the U.S. The Liberty pivotal study showed 100% success in the robotic navigation to target, and zero device-related adverse events, Microbot said. The study also showed a 92% relative reduction in radiation exposure for physicians.

Microbot plans for wider applications in the future

Microbot said Liberty is an endovascular robotic system for interventional physicians and hospitals seeking to improve procedural precision, safety, and efficiency. Unlike traditional manual techniques, Liberty offers a single-use, compact solution that enables controlled remote operation.

The surgical robot can be used in neurovascular, cardiovascular, and peripheral vascular procedures. The system includes a compact design and remote operating capabilities. Microbot also claimed that Liberty has the potential to lower procedure costs, increase procedure efficiency, and improve the overall quality of care.

In August, Microbot announced a new patent covering a modular robotic surgical system. The system includes a base and a plurality of tool-receiver units arranged as separate units. These units are independently and interchangeably attachable to the base. The company said the patent will potentially enable it to adapt Liberty in the future for a wider range of endovascular procedures.

With the latest patent, Microbot now has 12 patents globally and 57 patent applications pending. Microbot Medical is a pre-commercial-stage medical technology provider. It said its vision is to improve the quality of care for millions of patients and providers globally. The Braintree, Mass.-based company said Liberty is the first step toward its goal of rethinking how robotics can benefit healthcare. 

Surgical robotics will on the agenda at RoboBusiness, which takes place Oct. 15-16 in Santa Clara, Calif. Iman Jeddi, Ph.D., senior vice president and general manager of Intuitive’s multiport platform, will offer a rare look inside the redesign and launch of the da Vinci 5, the company‘s next-generation surgical robotics system.

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