Microbot Medical Inc. (MBOT) has achieved a significant milestone by receiving ISO 13485:2016 certification for its quality management system. This certification validates the company’s dedication to excellence in the development and manufacturing of its LIBERTY Endovascular Robotic Surgical System, a groundbreaking technology designed to revolutionize endovascular procedures.
The ISO 13485 certification is a critical step towards commercialization and regulatory compliance in both the European Union and the United States. With this certification, Microbot Medical is well-positioned to advance toward CE mark approval and seamlessly transition to the updated FDA regulations, paving the way for future growth and expansion in key markets.
The LIBERTY Endovascular Robotic Surgical System is designed to transform endovascular procedures by eliminating the need for large, expensive equipment, reducing radiation exposure for both patients and physicians, and minimizing physician strain. Its potential for remote operation aims to democratize access to endovascular interventions, making them more accessible and efficient.
The ISO 13485 certification is a testament to the strength of Microbot Medical’s quality management system. Achieving this certification signifies that the company has implemented a robust system specifically tailored to the medical device industry. This not only reinforces the company’s commitment to maintaining high standards in product development and manufacturing but also aligns Microbot Medical with the stringent regulatory requirements of the European Union’s Medical Device Regulation and the FDA’s revised Quality System Management Regulation.
The global robotic-assisted endovascular systems market is experiencing significant growth, driven by the increasing adoption of advanced systems that enhance efficiency and precision during procedures. The rising demand for minimally invasive surgeries that reduce patient trauma and recovery time further fuels this growth. A report by Future Market Insights estimates the market size to reach $214.7 million by 2033, growing at a CAGR of 8.6%.
Microbot Medical is actively advancing the LIBERTY Endovascular Robotic Surgical System with recent collaborations and clinical trial advancements. This month, the company partnered with Emory University to explore the integration of LIBERTY with an imaging system to develop an autonomous robotic system. The project aims to leverage CT guidance, artificial intelligence, and medical robotics to enhance procedural standardization, efficiency, and patient access.
In July, MBOT secured Institutional Review Board approval and a clinical trial agreement with Memorial Sloan Kettering Cancer Center (MSKCC) in New York City for its LIBERTY system. MSKCC will conduct the clinical trial under an Investigational Device Exemption (IDE) to support future FDA marketing submissions and commercialization. The trial also includes Brigham and Women’s Hospital and Baptist Hospital of Miami, which are already conducting clinical cases.
The same month, Microbot Medical announced that Baptist Hospital of Miami successfully conducted its first clinical procedure using the LIBERTY system, following its inclusion as a clinical trial site. This marks the second site to perform such a procedure after Brigham & Women’s Hospital.
These recent developments highlight Microbot Medical’s commitment to bringing the LIBERTY Endovascular Robotic Surgical System to market, which holds the potential to significantly improve patient outcomes and enhance the accessibility of minimally invasive procedures.
