Microbot Medical's LIBERTY Robotic System Gains FDA Clearance
Microbot Medical Achieves FDA Clearance for LIBERTY System
Microbot Medical Inc. (NASDAQ: MBOT), located in Hingham, Massachusetts, has made a significant leap in its product development journey. The company's innovative LIBERTY® Endovascular Robotic System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), making it the first single-use, remotely operated robotic system approved for peripheral endovascular procedures in the United States.
Transforming Endovascular Procedures
This FDA clearance signals a key milestone for Microbot Medical and its future in robotic-assisted healthcare. Harel Gadot, the company's Chairman, CEO, and President, expressed enthusiasm about this achievement, stating it not only validates their mission but also addresses critical healthcare needs. Gadot emphasizes that with this clearance, they are poised to complete the final activities necessary for commercial readiness and market entry.
Expanding Market Potential
The LIBERTY® system stands to tap into a vast market, with approximately 2.5 million peripheral endovascular procedures conducted annually in the United States alone. This innovative technology aims to make advanced robotic assistance more accessible to healthcare providers, reducing the need for extensive capital equipment and infrastructure typically associated with such advanced technologies.
Benefits of LIBERTY® System
Data from the pivotal trials of the LIBERTY® system highlights its success in robotic navigation, achieving a remarkable 100% success rate in reaching target vessels, with no device-related adverse events reported. Additionally, there was a notable 92% reduction in radiation exposure for physicians, enhancing the safety of health practitioners during procedures.
The remote operation of the LIBERTY® system is designed with provider ergonomics in mind, potentially alleviating the physical strain that many healthcare professionals experience during complex procedures. As such, the system not only aims to improve efficiency but also contributes to enhancing the overall quality of care delivered to patients.
Upcoming Events and Investor Engagement
Microbot Medical will participate in the H.C. Wainwright Annual Investor Conference in New York City, from September 8-10, 2025. Gadot is slated to present on September 9 at 9 AM ET and will discuss the prospective impact of the LIBERTY® system on the future of endovascular procedures. Investors and interested parties can tune into the live webcast through the company’s website.
About Microbot Medical Inc.
Microbot Medical is at the forefront of innovation, focusing on the development of advanced robotic technology aimed at revolutionizing endovascular procedures. With a strong foundation built on intellectual property and a commitment to healthcare advancement, the company is shaping the future of robotic-assisted medical care. Their LIBERTY® Endovascular Robotic System is pivotal in this mission, emphasizing safety, precision, and efficiency.
Frequently Asked Questions
What does FDA clearance mean for Microbot Medical?
The FDA clearance allows Microbot Medical to commercialize its LIBERTY® robotic system, marking a significant milestone in advancing endovascular procedures.
What is the primary function of the LIBERTY® system?
The LIBERTY® Endovascular Robotic System is designed for precision navigation in peripheral vascular procedures, enhancing safety and efficiency.
How many procedures could the LIBERTY® system impact annually?
It has the potential to impact approximately 2.5 million peripheral endovascular procedures performed annually in the U.S.
What advantages does the LIBERTY® system offer physicians?
Its robotic design significantly reduces radiation exposure and aims to improve ergonomics, minimizing physical strain during procedures.
How can investors learn more about Microbot Medical's initiatives?
Investors can access information and live updates through the company's website, especially during events such as the H.C. Wainwright Annual Investor Conference.
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