Microbot Medical Submits FDA 510(k) Premarket Notification for LIBERTY ® Endovascular Robotic System

On December 10, 2024, Microbot Medical Inc. announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its LIBERTY ® Endovascular Robotic System. This submission follows a successful multi-center, single-arm trial aimed at assessing the system’s performance and safety in human subjects undergoing Peripheral Vascular Interventions.

The company is optimistic about receiving FDA marketing clearance by the second quarter of 2025. Upon clearance, Microbot Medical anticipates launching commercialization activities in the United States. The innovative LIBERTY ® system is designed to revolutionize the peripheral endovascular space as the world’s first single-use, fully disposable robotic system.

Harel Gadot, Chairman, CEO, and President of Microbot Medical, expressed enthusiasm about this significant milestone, marking the company’s shift towards becoming a commercially focused entity. The company is gearing up for the anticipated U.S. launch and aims to cater to the over 2 million peripheral vascular procedures conducted annually in the United States.

The LIBERTY ® system stands out for its features, such as being single-use and disposable – attributes that eliminate the requirement for costly capital equipment and simplify access to robotics. The remote-controlled system is designed to minimize radiation exposure for medical professionals and enhance ergonomics, potentially reducing physical strain on healthcare providers. Moreover, Microbot Medical believes that LIBERTY ® has the potential to enhance procedure efficiency, lower costs, and elevate the quality of care.

Microbot Medical Inc. (NASDAQ: MBOT) is a medical technology company in the pre-commercial stage, aiming to enhance healthcare quality for patients and providers universally. The company’s vision is embodied in the LIBERTY ® Endovascular Robotic System, designed to remove existing barriers to utilizing advanced robotic systems.

Investors are advised to review the risk factors associated with Microbot Medical ® as disclosed in the company’s reports filed periodically with the Securities and Exchange Commission. Microbot Medical ® emphasizes its commitment to updating important forward-looking statements and information in compliance with legal obligations.

For further information on Microbot Medical ®, visit http://www.microbotmedical.com. Inquiries can be directed to [email protected].

This news article contains forward-looking statements and alludes to future financial performance, technological advancements, regulatory processes, and commercialization prospects. It emphasizes the importance of disclosed risk factors and the company’s dedication to regulatory compliance and information transparency.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Microbot Medical’s 8K filing here.

About Microbot Medical

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Microbot Medical Inc, a pre-clinical medical device company, engages in the research, design, and development of robotic endoluminal surgery devices targeting the minimally invasive surgery space. The company offers LIBERTY, an endovascular robotic surgical system which allows physicians to conduct a catheter-based procedure from outside the catheterization laboratory, and avoid radiation exposure, physical strain, and the risk of cross contamination for use in cardiovascular, peripheral, and neurovascular spaces.

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