Microbot Medical (MBOT) Gets Quality Certification for its System
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Microbot Medical Inc. MBOT recently announced the receipt of ISO 13485:2016 certification for its quality management system. This certification underscores the company's commitment to excellence in the development and manufacturing of its LIBERTY Endovascular Robotic Surgical System, marking an essential step toward 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 streamline its transition to the updated FDA regulations, paving the way for future growth and commercialization in key markets.
Microbot Medical is a clinical-stage medical device company focused on developing innovative micro-robotic technologies to enhance patient outcomes and improve access to minimally invasive procedures. The Investigational LIBERTY Endovascular Robotic Surgical System is designed to revolutionize endovascular procedures by eliminating the need for large, costly equipment, reducing radiation exposure and minimizing physician strain. With its potential for remote operation, the LIBERTY system aims to democratize endovascular interventions, making them more accessible and efficient.
Significance of the Certification
The ISO 13485 certification validates the strength of the company's quality management system. Achieving ISO 13485:2016 certification is a critical milestone for Microbot Medical, as it signifies that the company has implemented a rigorous quality management system tailored to the medical device industry. This certification not only validates the company's dedication 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.
Industry Prospects
Per a report in Future Market Insights, the robotic-assisted endovascular systems market size was worth $94 million in 2023. It is anticipated to reach $214.7 million by 2033 at a CAGR of 8.6%.
The robust growth will be primarily driven by the increasing adoption of advanced systems that enhance efficiency and precision during procedures, along with the rising demand for innovative, minimally invasive surgeries that reduce patient trauma and recovery time.
Recent LIBERTY Endovascular Robotic Surgical System Developments
This month,Microbot Medical and Emory University agreed to explore potential collaboration on autonomous robotics in endovascular procedures. Emory will lead the feasibility study of integrating the LIBERTY Endovascular Robotic Surgical System with an imaging system to develop an autonomous robotic system. The project aims to combine CT guidance, artificial intelligence, and medical robotics to enhance procedural standardization, efficiency and patient access.