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08. September 2025
Microbot Medical Achieves Historic Fda Clearance For Groundbreaking Endovascular Robot
Microbot Medical, a medical technology provider based in Braintree, Massachusetts, has made significant strides in the field of endovascular robotics with the recent FDA clearance of its Liberty endovascular surgical robot. This milestone marks a crucial step forward for the company, as it now holds the distinction of being the first FDA-cleared single-use, remotely operated robotic system for peripheral endovascular procedures.
The announcement was met with enthusiasm from Harel Gadot, chairman, CEO, and president of Microbot Medical, who stated that this achievement validates the company’s mission to expand access to advanced robotic technologies while addressing critical unmet needs in healthcare. “Obtaining FDA 510(k) clearance for Liberty marks a defining moment for Microbot Medical and, we believe, for the future of endovascular robotics,” Gadot said.
The Liberty robot is designed to improve procedural precision, safety, and efficiency in interventional physicians and hospitals. Unlike traditional manual techniques, Liberty offers a single-use, compact solution that enables controlled remote operation. The system can be used in neurovascular, cardiovascular, and peripheral vascular procedures, making it an attractive option for a wide range of applications.
One of the key features of Liberty is its ability to reduce radiation exposure to physicians and staff. According to Microbot Medical, the surgical robot was designed with a remote control to significantly decrease radiation levels, improving ergonomics and reducing physical strain on healthcare providers. This could lead to improved patient outcomes and enhanced overall quality of care.
The company’s vision is to improve the quality of care for millions of patients and providers globally, and the Liberty robot is seen as a critical step towards achieving this goal. “We believe, based on feedback from physicians and the medical community, that Liberty is positioned to redefine the peripheral endovascular space with the introduction of the world’s first commercially available single-use robotic system,” Gadot stated.
Microbot Medical has also announced plans for wider applications in the future, including the potential use of Liberty in other endovascular procedures. The company has filed a new patent covering a modular robotic surgical system, which includes a base and a plurality of tool-receiver units arranged as separate units. These units are independently and interchangeably attachable to the base, allowing for greater flexibility and adaptability.
The company’s pipeline is robust, with 12 patents globally and 57 patent applications pending. Microbot Medical’s recent expansion of its U.S. operations ahead of the IDE submission demonstrates its commitment to commercialization and market entry.
Surgical robotics will be a key topic at RoboBusiness, which takes place on October 15-16 in Santa Clara, California. 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.
The FDA clearance of Liberty is also significant, as it marks a pivotal milestone for Microbot Medical. The company expects to complete its final commercial activities that were contingent on marketing clearance, positioning itself for commencement of commercialization in the U.S. and entry into global markets. With over 2.5 million annual U.S. peripheral vascular procedures, Microbot Medical sees an enormous opportunity for growth.
The Liberty pivotal study showed a remarkable success rate, with 100% navigation to target and zero device-related adverse events. The study also demonstrated a 92% relative reduction in radiation exposure for physicians, highlighting the robot’s potential to improve patient outcomes while reducing healthcare costs.
Microbot Medical has made significant strides in its pre-commercial stage, including completing the first procedure in a clinical trial using its surgical robot at Brigham and Women’s Hospital (BWH) in Boston. The company also secured a $2.154 million settlement of a lawsuit involving a securities purchase agreement in January.
As the medical technology landscape continues to evolve, companies like Microbot Medical are pushing the boundaries of innovation and improvement. With Liberty leading the way, the future of endovascular robotics looks bright, and we can expect significant advancements in the years to come.
The company’s vision of rethinking how robotics can benefit healthcare is inspiring, and its commitment to improving quality of care for millions of patients and providers globally is admirable. As Microbot Medical continues to drive innovation and expansion, it’s clear that this company is poised for greatness.
Liberty has the potential to redefine the peripheral endovascular space with its introduction as the world’s first commercially available single-use robotic system. With 510(k) clearance in hand, Microbot Medical is well-positioned to capitalize on this opportunity, and we can expect significant growth and expansion in the coming years.
The company’s modular design and remote operating capabilities make Liberty an attractive option for hospitals and interventional physicians seeking to improve procedural precision, safety, and efficiency. By reducing radiation exposure and improving ergonomics, Liberty has the potential to lower procedure costs, increase efficiency, and enhance overall quality of care.
As we look to the future, it’s clear that Microbot Medical is at the forefront of innovation in medical technology. With its commitment to improving quality of care and rethinking how robotics can benefit healthcare, this company is setting a new standard for excellence in the industry.
The recent FDA clearance of Liberty marks a significant milestone for Microbot Medical, but it’s just the beginning. As the company continues to drive innovation and expansion, we can expect significant advancements in the years to come. With its vision of improving quality of care for millions of patients and providers globally, Microbot Medical is poised for greatness.
The introduction of Liberty as the world’s first commercially available single-use robotic system has sent shockwaves through the medical technology landscape. With its unique design and capabilities, this robot is set to revolutionize the field of endovascular robotics.
By reducing radiation exposure and improving ergonomics, Liberty has the potential to lower procedure costs, increase efficiency, and enhance overall quality of care. The company’s modular design and remote operating capabilities make it an attractive option for hospitals and interventional physicians seeking to improve procedural precision, safety, and efficiency.
As Microbot Medical continues to drive innovation and expansion, we can expect significant advancements in the years to come. With its commitment to improving quality of care and rethinking how robotics can benefit healthcare, this company is setting a new standard for excellence in the industry.