Rob Surgical Secures EU CE Mark for ROB® Surgical Robot

Rob Surgical Systems has received the European Union CE mark for the use of its ROB® surgical robot and associated instruments in urological surgical procedures. The certification represents a major milestone for the company, confirming that the ROB® platform meets the European Union’s regulatory requirements for safety, quality and clinical performance.

Following this initial certification in urology, Rob Surgical is advancing the expansion of the ROB® platform into additional surgical specialties, including general surgery and gynecology. The company is now entering a new phase focused on the deployment and integration of the ROB® system across European healthcare systems, while progressively broadening its clinical applications.

“The CE mark is one of the defining milestones in Rob Surgical’s history,” said Mario Ferradosa, CEO of Rob Surgical Systems. “This achievement reflects more than 15 years of scientific research, technological innovation unique to Spain, clinical development and regulatory discipline, made possible by an exceptional team. It also marks the beginning of a new chapter for the company, as we continue to advance our technology and expand its capabilities across multiple surgical specialties, including general surgery and gynecology.”

ROB® is a robotic surgery platform designed for minimally invasive procedures in specialties including urology, general surgery and gynecology. The system integrates four robotic arms on a single cart and features an open architecture designed to facilitate integration into existing operating rooms without requiring hospitals to replace current equipment or significantly modify established surgical workflows.

The European CE mark for urology concludes a clinical development process that began in April 2023, when the first procedures using the ROB® system were performed on patients at Hospital Clínic de Barcelona.

The milestone follows the opening of Rob Surgical’s first manufacturing facility in El Prat de Llobregat (Catalonia, Spain) in early 2026. The new plant enables the company to manufacture the ROB® system and progressively scale production capacity ahead of its commercial rollout.

Source: Rob Surgical

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