#Hong Kong #Robotic Surgery #Cornerstone Robotics #Sentire® Surgical System

Cornerstone Robotics Achieves CE Mark for Sentire® Surgical System

Cornerstone Robotics (CSR), a prominent name in surgical robotics based in Hong Kong, has recently announced a significant milestone. Their innovative, minimally invasive Sentire® Endoscopic Surgical System has successfully obtained the CE Mark certification in accordance with the European Union's Medical Devices Regulation (MDR). This marks a pivotal step for CSR, granting them official access to the European healthcare markets.

Regulatory Approval and Clinical Validation

The Sentire® Surgical System represents an advanced robotic platform designed to enhance various surgical processes. With the securement of the CE Mark, this system meets rigorous safety, efficiency, and quality management standards established by European regulators, thus enabling its use by surgeons worldwide. Prior to this achievement, CSR had already entered the UK market, partnering with Portsmouth Hospitals University NHS Trust since 2025 to conduct a clinical study that aligned with the required benchmarks.

The ongoing research has generated a wealth of clinical data, facilitating evidence-based studies, training protocols, and the integration of the system into clinical practice. Numerous complex procedures across specialties—including urology, gynecology, and gastrointestinal surgery—have successfully been performed using the Sentire® Surgical System in the UK, yielding favorable outcomes and commendable feedback from medical professionals.

Localized Services for Global Expansion

Since its inception, CSR has adopted a “think global, act local” strategy, focusing on integrating local physicians and patients into their operations. The establishment of a subsidiary in the UK in 2025 was a strategic move towards providing comprehensive customer service that includes professional training, technical support, and post-sales service. Through multiple training sessions in the UK, CSR aims to familiarize clinical teams with the Sentire® system, preparing them for extensive commercial deployment.

Robust Research and Development Underpins Growth

CSR’s robust in-house research and development capabilities and vertically integrated business model provide a competitive advantage for global expansion. This high level of technology integration not only fortifies clinical outcomes but enhances supply chain stability and ensures operational efficiency, thereby promoting long-term innovation.

CEO Samuel Au emphasized that securing the CE certification is a significant milestone in transitioning Cornerstone Robotics from a technological innovator to a global supplier of clinical solutions. He highlighted that every phase of their journey reflects a strong commitment to innovation and clinical value.

As CSR looks to the future, it expects to continue expanding into key global markets and seeks partnerships with leading medical institutions to provide high-quality robotic surgical solutions to an ever-increasing number of physicians and patients around the world.

The CE certification not only endorses CSR's entrance into the European market but also showcases its ambition to enlarge its global footprint. In November 2025, CSR successfully raised approximately $200 million in a funding round, underscoring investor confidence in its growth potential and global business opportunities. Supported by patented technological innovations and strategic resources, Cornerstone Robotics is well-positioned to accelerate the access to high-quality surgical robotic solutions on a global scale.

About Cornerstone Robotics

Cornerstone Robotics is an innovative unicorn company dedicated to delivering leading medical innovations for a healthier world. By advancing surgical care through state-of-the-art robotic systems, they are making high-quality healthcare more accessible and effective. With three global R&D centers and six business hubs worldwide, the company operates a 30,000 square foot manufacturing facility in China. The Sentire® Surgical System, developed entirely in-house, has undergone multi-disciplinary clinical trials and has received market approval in China, the European Union, and Singapore, pushing the envelope of quality surgical care across the globe.

For more information, visit Cornerstone Robotics.