#China #Hong Kong #CE Mark #Cornerstone Robotics #Sentire®

Cornerstone Robotics' Sentire® Surgical System Achieves CE Mark Approval

On May 25, 2026, Cornerstone Robotics (CSR), a pre-eminent innovator in the field of surgical robotics, proudly announced that its advanced endoscopic platform, the Sentire® Surgical System, has officially received the CE Mark certification in accordance with the European Medical Device Regulation (MDR). This certification confirms the system's compliance with stringent European regulatory requirements, allowing Cornerstone Robotics to gain a formidable foothold in the European healthcare market, specifically for minimally invasive surgeries in areas like general surgery, gynecology, thoracic surgery, and urology.

Regulatory Approval and Clinical Validation

The Sentire® Surgical System represents a significant advancement in the world of surgical technology, combining sophisticated workflows with cutting-edge integrated engineering and imaging technologies. Achieving CE certification not only validates the system's safety, efficacy, and quality management efforts but also showcases CSR's commitment to providing innovative solutions to healthcare providers and patients worldwide.

Cornerstone Robotics has been active in the UK healthcare landscape since establishing its operations there. Since 2025, the company has collaborated with the Portsmouth Hospitals University NHS Trust (PHU) to conduct clinical research involving the Sentire® system, amassing valuable real-world clinical data to support evidence-based research, develop training protocols, and facilitate clinical adoption. Thus far, the Sentire® system has enabled numerous successful procedures across key specialties such as urology and gynecology, yielding favorable outcomes for patients and high satisfaction rates among medical professionals.

Localized Services and Robust Global Expansion Strategy

Since its inception, CSR has embraced a global strategy while simultaneously localizing its services to meet the needs of healthcare professionals and patients in various regions. In Europe, CSR formally established its UK subsidiary in 2025, providing a comprehensive range of services that include professional training, clinical technical support, and post-sale services. The company has conducted multiple training sessions in the UK, empowering clinical teams with the necessary proficiency and confidence in utilizing the Sentire® system, thereby laying a strong foundation for large-scale commercial implementation.

CSR's comprehensive in-house R&D capabilities and vertical integration mark the foundation of its competitive edge and global growth strategy. The high level of technological integration not only drives robust clinical performance and operational stability but also enhances agility and supports long-term innovation.

Looking Ahead

Professor Samuel Au, the founder and CEO of Cornerstone Robotics, emphasized the importance of CE certification in their journey from being an innovative technology company to a global provider of clinical solutions. "This recognition marks a significant milestone in our evolution," he stated. "Every achievement, from our initial clinical research in Portsmouth to obtaining European regulatory approval, demonstrates our unwavering commitment to our innovative essence, product excellence, and clinical value. Moving forward, we aim to continue our expansion into key global markets and collaborate with leading medical institutions to provide high-quality surgical robotic solutions to more healthcare providers and patients around the globe."

The CE certification not only solidifies Cornerstone Robotics' expansion into the European market but also enhances its global marketing strategy. In a remarkable demonstration of investor confidence, the company successfully completed a funding round in November 2025 with oversubscriptions amounting to approximately $200 million, underscoring institutional investors' belief in CSR's potential for sustained growth and its global business capabilities.

With its proprietary technological innovations and strong strategic resources, Cornerstone Robotics is well-positioned 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 unicorn enterprise in the domain of surgical robotics, guided by a vision of leading medical innovations for a healthier world. The company enhances surgical care through state-of-the-art robotic systems that make high-quality healthcare more accessible and efficient on a global scale. With three R&D centers and six business offices worldwide, CSR has established a 30,000 square meter manufacturing facility in China. The Sentire® surgical system, developed entirely in-house, has undergone multi-specialty clinical trials and received marketing approvals in China, the EU, and Singapore, thus promoting high-quality surgical care worldwide. For more information, please visit their website at https://en.csrbtx.com/.