Moon Surgical Secures FDA Clearance for Maestro™ Connectivity and Predetermined Change Control Plan for AI-Powered ScoPilot®
New York, NY – July 2, 2025 – Moon Surgical, a pioneering medical technology company dedicated to advancing robotic surgery, today announced it has received U.S. Food and Drug Administration (FDA) clearance for its Maestro™ Connectivity and Predetermined Change Control Plan (PCCP) for its AI-powered robotic surgical system, ScoPilot®. This significant milestone marks a crucial step forward in the widespread adoption and continuous improvement of robotic-assisted procedures, underscoring Moon Surgical’s commitment to innovation and patient care.
The FDA clearance for Maestro™ Connectivity enables seamless and secure integration of the ScoPilot® system with hospital information systems (HIS) and electronic health records (EHR). This interoperability is vital for enhancing surgical workflow efficiency, providing clinicians with real-time patient data, and facilitating comprehensive data analysis for improved surgical outcomes. By allowing for the smooth exchange of critical information, Maestro™ Connectivity aims to streamline pre-operative planning, intra-operative decision-making, and post-operative follow-up.
Furthermore, the FDA’s clearance of the Predetermined Change Control Plan (PCCP) for ScoPilot® is a testament to Moon Surgical’s robust approach to innovation and regulatory compliance. A PCCP allows for pre-defined modifications to a medical device that are implemented without requiring a new FDA submission for each individual change. This forward-thinking regulatory strategy will enable Moon Surgical to more rapidly iterate and enhance the AI algorithms and functionalities within the ScoPilot® system, ensuring that surgeons and patients benefit from the latest advancements in artificial intelligence and robotic technology.
“We are thrilled to receive FDA clearance for Maestro™ Connectivity and our Predetermined Change Control Plan,” said [Name and Title of Moon Surgical Spokesperson, e.g., Dr. Michel Arnaud, CEO of Moon Surgical]. “This dual clearance represents a pivotal moment for Moon Surgical and, more importantly, for the future of surgical care. Maestro™ Connectivity will empower surgical teams with the data and integration they need to optimize patient care, while the PCCP allows us to accelerate the development and deployment of our AI-powered innovations. Our goal is to make complex surgical procedures safer, more efficient, and more accessible, and these clearances are instrumental in achieving that mission.”
The ScoPilot® system is designed to augment surgeons’ capabilities, offering enhanced precision, control, and visualization during minimally invasive procedures. The integration of advanced AI is intended to provide intelligent assistance, potentially leading to reduced operative times, improved patient outcomes, and faster recovery.
This FDA clearance is expected to accelerate the adoption of the ScoPilot® system in leading hospitals across the United States, paving the way for a new era of AI-enhanced robotic surgery. Moon Surgical remains dedicated to collaborating with healthcare professionals to further refine its technology and deliver transformative solutions that benefit patients worldwide.
About Moon Surgical
Moon Surgical is a medical technology company focused on developing and commercializing advanced robotic solutions for minimally invasive surgery. The company’s flagship product, ScoPilot®, leverages artificial intelligence and cutting-edge robotics to enhance surgical performance, improve patient outcomes, and increase surgical efficiency. Moon Surgical is committed to pushing the boundaries of surgical innovation to make advanced surgical care more accessible and effective.
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