CE Mark Awarded to Cornerstone Robotics’ Sentire Surgical System

Cornerstone Robotics’ (CSR) Sentire Endoscopic Surgical System has gained CE Mark certification under the Medical Device Regulation (MDR), covering minimally invasive surgical procedures in general surgery, gynecology, thoracic, and urology.

The Sentire Surgical System is a high-end surgical robotic platform that combines clinical workflows with integrated engineering, software, and imaging technologies. Achieving CE certification affirms that its safety, efficacy, and quality management system fully comply with stringent European regulatory standards, and is now positioned to serve physicians and patients worldwide.

The company established an early presence in the United Kingdom. Since 2025, CSR has partnered with Portsmouth Hospitals University NHS Trust (PHU) to undertake a clinical investigation of the Sentire Surgical System, steadily accumulating real-world clinical data to support evidence-based research, training protocol development, and clinical adoption. To date, the Sentire Surgical System has completed numerous complex procedures in the United Kingdom, spanning core specialties including urology, gynecology, and upper and lower gastrointestinal surgery. The investigation achieved positive patient outcomes, and clinicians were very satisfied with the system’s performance. 

From its inception, CSR has embraced a “think global, act local” approach—pursuing a global strategy empowered by local physicians and patients. In Europe, CSR formally established its U.K. subsidiary in 2025, initiating a one-stop service provision encompassing professional training, clinical technical support, and after-sales service. The company has already conducted multiple U.K. training sessions to help clinical teams rapidly build proficiency and confidence in operating the Sentire Surgical System, thereby establishing a solid foundation for scaled commercial rollout.

“Receiving CE Certification marks a major milestone in Cornerstone Robotics’ evolution from a technology innovator to a global clinical solutions provider,” CSR Founder/CEO Professor Samuel Au said. “From our first clinical investigation in Portsmouth, U.K., 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.”

CE certification marks a major milestone in Cornerstone Robotics’ expansion into the European market and broader global commercialization journey. In November 2025, the company completed a $200 million oversubscribed financing round. Supported by proprietary technological innovation and strong strategic resources, CSR executives say the firm is well positioned to accelerate the global adoption of surgical robotic solutions for physicians and patients.

Cornerstone Robotics (CSR) advances surgical care with robotic systems that make high-quality healthcare more accessible and efficient globally. With three global R&D hubs and six business centers worldwide, the company has established a 30,000-square-meter manufacturing facility in China. Developed in-house, the Sentire Surgical System has completed multi-specialty clinical trials and received market approval across China, the European Union, and Singapore.