#Hong Kong #CE Mark #Cornerstone Robotics #Sentire

Cornerstone Robotics Expands Horizons with CE Mark for Sentire® Surgical System

In a transformative announcement, Cornerstone Robotics (CSR), a leading innovator in surgical robotics based in Hong Kong, has achieved a monumental milestone by receiving the CE mark certification under the Medical Device Regulations (MDR) for its cutting-edge Sentire® Surgical System. This approval allows the company to enter the European market, catering to the needs of surgeons and patients across various specialties, including general surgery, gynecology, thoracic, and urology.

The Sentire® Surgical System is a sophisticated robotic platform that marries advanced clinical workflows with integrated imaging, software, and engineering technologies. Having obtained CE certification, CSR can now ensure that its product meets the stringent safety and effectiveness standards mandated by European regulations. This advancement not only opens new avenues for business but also confirms CSR’s commitment to enhancing the global surgical landscape.

Since its inception, CSR has been relentlessly working on establishing its presence in the United Kingdom, initiating collaborations with major health institutions such as the Portsmouth Hospitals University NHS Trust (PHU). Beginning in 2025, CSR engaged in a clinically-compliant study of the Sentire® system, systematically gathering real-world clinical data to bolster evidence-based research, inform training protocol developments, and facilitate clinical adoption. As of now, the Sentire® system has successfully conducted numerous complex procedures across UK healthcare facilities, spanning specialties like urology and gynecology, yielding positive patient outcomes and high clinician satisfaction scores.

Strengthening Global Presence Through Localized Services

The company's philosophy of 'think globally, act locally' is being so vividly enacted through CSR’s strategic growth plan, leveraging local support from medical professionals and patients alike. In 2025, CSR solidified its UK subsidiary, catalyzing a unique service delivery model that encompasses professional training, clinical technical support, and post-sale services. This tailored approach has already led to multiple training sessions across the UK, ensuring clinical teams excel in operating the Sentire® system and establishing a firm foundation for large-scale commercialization.

The comprehensive in-house research and development capabilities at CSR, coupled with its vertical integration strategy, provide a competitive edge and establish a robust framework for high-quality global expansion. The company's technological integration enables notable clinical performance, supply chain resilience, and operational stability while also fostering long-term innovation.

According to Professor Samuel Au, founder and CEO of CSR, "Receiving the CE certification signifies a critical turning point for Cornerstone Robotics, as we transition from a technology innovator to a global clinical solutions provider. Each milestone we reach—from our initial clinical trials in Portsmouth to now obtaining European regulatory approval—underscores our commitment to exclusive innovation, product excellence, and clinical value. We aim to continue expanding into major global markets and fostering partnerships with leading medical institutions, ensuring that high-quality surgical robotic solutions reach a broader patient population around the world."

The CE certification represents a pivotal development in Cornerstone Robotics’ expansion into the European market and its global commercialization journey. In November 2025, CSR successfully completed an oversubscribed funding round, securing around $200 million, which affirms the confidence of prominent international investors in its long-term growth potential and global commercial capabilities.

With exclusive technological innovations and solid strategic resources backing its operations, Cornerstone Robotics is poised to accelerate the global adoption of accessible, high-quality surgical robotic solutions for medical professionals and patients worldwide.

About Cornerstone Robotics (CSR)

Cornerstone Robotics (CSR) is a pioneering entity in the surgical robotics sector, propelled by a vision to advance medical innovations for a healthier world. The firm enhances surgical care through advanced robotic systems that make high-quality healthcare more accessible and efficient on a global scale. With three global research and development centers and six business hubs, CSR has set up a comprehensive 30,000 square meter manufacturing facility in China. The Sentire® Surgical System was developed entirely in-house and has undergone multi-specialty clinical trials, receiving commercialization approval in China, the European Union, and Singapore, thereby pushing forward the frontiers of surgical care worldwide.

For more information, visit Cornerstone Robotics.