Robotic system LIBERTY, developed by pre-clinical medical device company Microbot Medical, has achieved a significant milestone by securing approval from the U.S. Food and Drug Administration (FDA) to proceed with a pivotal human clinical trial. This approval is a crucial step in the investigational device exemption (IDE) application process for the LIBERTY robotic system.
The pivotal clinical trial, set to take place in the United States, marks a significant advancement for Microbot Medical. The study will be conducted in collaboration with a leading academic medical center, which has already signed a clinical trial service agreement with the company. Efforts are also underway to engage additional prominent medical centers to participate in the trial, further expanding its scope and reach. In addition to these preparations, Microbot Medical is completing the necessary biocompatibility tests as required by its IDE application.
The LIBERTY robotic system is specifically designed to improve the efficiency and safety of endovascular procedures. One of its primary advantages is the elimination of the need for large and expensive capital equipment, which not only reduces costs but also decreases the physical strain and radiation exposure experienced by physicians during these procedures.
Microbot Medical’s LIBERTY Robotic System Receives FDA Approval for Clinical Study
Microbot Medical’s CEO, President, and Chairman, Harel Gadot, expressed confidence in the LIBERTY system following the FDA’s recent authorization. He stated, “The recent authorization by the FDA to commence our pivotal clinical study, following submission of the results of our extensive pre-clinical studies and tests, reinforces our confidence in our innovative technology. It is also a testament to our commitment to meet meaningful milestones as we continue our path towards potential regulatory clearance and subsequent commercialization in the U.S. and other regions across the globe.”
The LIBERTY robotic system’s design is geared towards enhancing the capabilities of physicians performing endovascular surgeries. By providing a more efficient and safer alternative to traditional methods, the LIBERTY robotic system aims to transform the landscape of surgical robotics. The system’s ability to eliminate the need for bulky and costly equipment is particularly noteworthy, as it significantly reduces the operational burden on healthcare facilities. Moreover, by minimizing radiation exposure, the LIBERTY system helps protect physicians, thereby promoting a safer working environment.
In addition to the clinical advancements, Microbot Medical has also secured funding to further develop the LIBERTY robotic system. In June 2023, the company received NIS 1.62 million ($440,000) from the Israel Innovation Authority. This funding is intended to support the advancement of the manufacturing process for the LIBERTY system, ensuring that the company can scale production to meet future demand.
The clinical study for the LIBERTY robotic system is a critical component of Microbot Medical’s broader strategy to achieve regulatory clearance and commercialization. By demonstrating the system’s efficacy and safety in a controlled clinical setting, the company aims to gather the necessary data to support its IDE application. Successful completion of the trial will pave the way for further regulatory approvals, not only in the U.S. but also in other regions around the world.
FDA Approves Microbot Medical’s LIBERTY Robotic System for Endovascular Surgery Trial
The LIBERTY robotic system represents a significant innovation in the field of endovascular surgery. Its design prioritizes both the efficiency of the surgical process and the safety of the medical personnel involved. By reducing the need for large equipment and minimizing radiation exposure, the system addresses two of the major challenges faced by physicians performing endovascular procedures.
Microbot Medical’s commitment to innovation and excellence is evident in the development and clinical testing of the LIBERTY robotic system. The company’s proactive approach to securing collaborations with leading medical centers and obtaining necessary funding underscores its dedication to advancing medical technology and improving patient outcomes. As the pivotal clinical trial progresses, Microbot Medical is poised to make significant strides toward the widespread adoption and commercialization of the LIBERTY robotic system, potentially revolutionizing the field of robotic surgery.
In summary, the FDA’s approval for the pivotal clinical trial of the LIBERTY robotic system marks a major milestone for Microbot Medical. This development not only reinforces the company’s confidence in its innovative technology but also sets the stage for future regulatory clearances and commercialization efforts. With continued support from key stakeholders and a clear focus on achieving meaningful milestones, Microbot Medical is well-positioned to lead the way in transforming endovascular surgical procedures.
Resource: Microbot Medical, June 03, 2024
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