#Hong Kong #CE Mark #Cornerstone Robotics #Sentire Surgical

Cornerstone Robotics Makes Strides with CE Mark Certification for Sentire® Surgical System

In a significant development, Cornerstone Robotics (CSR), a trailblazer in the surgical robotics field headquartered in Hong Kong, has officially secured CE mark certification for its Sentire® Surgical System. This milestone, which complies with the Medical Device Regulation (MDR), opens doors for minimally invasive surgical practices across various disciplines such as General Surgery, Gynecology, Thoracic Surgery, and Urology in the European market.

Achieving this certification not only validates the safety and effectiveness of the Sentire® system but also reinforces CSR's commitment to delivering high-quality surgical solutions to healthcare professionals and patients worldwide.

A Commitment to Excellence and Safety

The Sentire® Surgical System stands out due to its advanced integration of engineering, software, and imaging technologies tailored for surgical procedures. The CE certification signifies that the system meets rigorous European safety and quality standards, enabling Cornerstone Robotics to provide innovative solutions to medical facilities across Europe.

CSR's outreach efforts began in the UK, beginning in 2025 when it teamed up with the Portsmouth Hospitals University NHS Trust (PHU) to conduct compliant clinical investigations. This partnership has facilitated the collection of real-world clinical data, essential for further backing of the Sentire® system's efficacy. The outcomes of numerous procedures have not only met but exceeded expectations, resulting in positive feedback from both patients and healthcare providers.

Localized Approach to Global Strategy

Cornerstone Robotics has embraced a ‘think global, act local’ strategy since inception, enhancing its ability to cater to the unique needs of local physicians and their patients. In alignment with this strategy, CSR established a UK subsidiary in 2025, which offers comprehensive services including professional training, technical support, and aftercare services.

These initiatives have already resulted in successful training sessions for clinical teams, boosting their confidence and proficiency in utilizing the Sentire® Surgical System. This localized service provision lays a robust groundwork for the broader commercialization of CSR’s technology.

Full-Stack R&D and Vertical Integration as Competitive Advantage

Cornerstone Robotics boasts an exceptional capability with its full-stack in-house research and development model, which is crucial for fostering innovation and sustaining competitive outcomes. This vertical integration presents several advantages, such as improved clinical results, supply chain dependability, and operational consistency. Coupled with enhanced agility, CSR is poised for sustained innovation and growth.

Professor Samuel Au, the Founder and CEO of Cornerstone Robotics, highlighted the significance of the CE certification: “This achievement marks a pivotal point in Cornerstone Robotics' progression from being a technological innovator to a comprehensive global clinical solutions provider. Our journey—from clinical investigations in Portsmouth, UK, to receiving European regulatory approval—showcases our dedication to innovation and clinical value.”

Expanding Horizons: Future Prospects

The CE certification not only signifies CSR's current achievements but also positions it favorably for future expansion in the European market and beyond. In November 2025, CSR demonstrated substantial growth by successfully finalizing a financing round that raised approximately US$200 million, indicating strong investor confidence in its long-term vision and commercial potential.

Fueled by advanced technological innovations and strategic resources, Cornerstone Robotics aims to accelerate worldwide adoption of accessible and high-quality surgical robot solutions, enhancing care for physicians and patients alike.

About Cornerstone Robotics

Founded with a commitment to transform surgical care, Cornerstone Robotics is a leading figure in the surgical robotics domain. With production and R&D facilities distributed globally, including a 30,000-square-meter manufacturing hub in China, CSR continues to produce cutting-edge robotic systems. The Sentire® Surgical System has successfully passed clinical trials and received market approval not only in China and Europe but also in Singapore, paving the way for superior surgical care worldwide.

For more information about Cornerstone Robotics and the Sentire® Surgical System, please visit CSR's official website.