Surgical Robotic System Gains CE Mark for Minimally Invasive Procedures

Cornerstone Robotics’ (CSR; Hong Kong, China) Sentire Endoscopic Surgical System (Sentire Surgical System) has received European Union CE mark certification under the Medical Device Regulation (MDR) for minimally invasive procedures in general surgery, gynecology, thoracic surgery, and urology. The certification grants the platform access to European markets and confirms compliance with EU requirements for safety, performance, and quality management.

Developed entirely in-house, the Sentire Surgical System is a multi-specialty surgical robotic platform supported by a one-stop service model that includes professional training, clinical technical support, and after-sales service. These resources are designed to help hospital teams move from initial evaluation to routine clinical use.

The technology combines clinical workflows with integrated engineering, software, and imaging components. This high level of technological integration is described as enabling strong clinical performance while reinforcing supply‑chain resilience and operational stability. The company’s vertically integrated approach is positioned to support continued innovation over time.

Since 2025, CSR has partnered with Portsmouth Hospitals University NHS Trust (PHU) in the UK on a fully compliant clinical investigation of the Sentire Surgical System. The platform has been used for numerous complex procedures spanning urology, gynecology, and upper and lower gastrointestinal surgery. The investigation achieved the patient outcomes, and clinicians were very satisfied with the system’s performance.

To deepen local support, the company established a UK subsidiary in 2025 and has conducted multiple training sessions to accelerate team proficiency. These activities are intended to create a solid foundation for scaled rollout. The system has completed multi‑specialty clinical trials and received market approval across China, the European Union, and Singapore.

“Receiving CE Certification marks a major milestone in Cornerstone Robotics' evolution from a technology innovator to a global clinical solutions provider. From our first clinical investigation in Portsmouth, UK, to achieving European regulatory approval, each step of the journey reflects our commitment to proprietary innovation, product excellence, and clinical value. Looking ahead, we will continue expanding into key global markets and partnering with leading medical institutions to bring high-quality surgical robotic solutions to more physicians and patients worldwide,” said Professor Samuel Au, Founder and CEO of Cornerstone Robotics.

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