Milestone Achieved: Dual Regulatory Approvals Propel Sentire® into Key Global Markets

On May 26, 2026, Cornerstone Robotics, a pioneering surgical robotics company headquartered in Hong Kong, proudly announced that its proprietary Sentire® Surgical System has attained the prestigious CE mark certification under the European Union’s Medical Device Regulation (MDR). Simultaneously, the system received approval from Singapore’s Health Sciences Authority (HSA). These certifications authorize the use of the Sentire® system in minimally invasive surgeries across multiple specialties, including General Surgery, Gynecology, Thoracic, and Urology. This dual regulatory success marks a significant breakthrough, positioning Cornerstone Robotics as the first Hong Kong-based surgical robotics firm to achieve concurrent EU certification and comprehensive European clinical validation, thereby cementing Hong Kong’s role in the global medical device innovation landscape.

Integrating Advanced Technology with Rigorous Clinical Validation

The Sentire® Surgical System represents a sophisticated integration of clinical workflow optimization with cutting-edge engineering, software, and imaging technologies. The attainment of CE certification confirms that the system meets stringent international standards for safety, efficacy, and quality management. This endorsement underscores the platform’s readiness to support surgeons and patients worldwide with reliable, high-performance robotic assistance.

Beyond regulatory compliance, Cornerstone Robotics has actively pursued extensive clinical validation in Europe. Leveraging its tri-continental R&D centers and early establishment in the UK, the company has harnessed European clinical expertise to refine the system’s design and functionality. Since 2025, a collaborative clinical trial with Portsmouth Hospitals University NHS Trust (PHU) has been underway, generating robust real-world data across complex procedures in urology, gynecology, and gastrointestinal surgery. The trial has yielded favorable patient outcomes and high clinician satisfaction, reinforcing the system’s clinical value and operational reliability.

Similarly, Singapore’s HSA certification-recognized for its rigorous evaluation standards-further validates the Sentire® system’s global compliance and quality. This dual approval from two of the world’s most demanding regulatory bodies highlights Cornerstone Robotics’ commitment to excellence across diverse healthcare markets.

Expanding Global Footprint with Comprehensive Localized Support

Embracing its “From Hong Kong to the World” vision, Cornerstone Robotics has intensified its localization strategy to better serve international clients. In 2025, the company launched its UK subsidiary to provide end-to-end services, including specialized training, clinical technical assistance, and after-sales support. Multiple training programs have been conducted for surgeons, operating room nurses, and hospital technicians, accelerating proficiency and confidence in the Sentire® system and laying the groundwork for broader commercial adoption across Europe.

In parallel, Cornerstone Robotics is strengthening its presence in the Asia-Pacific region through strategic partnerships. A notable collaboration involves a tripartite Memorandum of Understanding with Singapore’s National Healthcare Group (NHG) and the Lee Kong Chian School of Medicine at Nanyang Technological University. In April 2026, the Sentire® system was installed at Woodlands Hospital under NHG, where it is actively used for surgical team training, system evaluation, and workflow integration. This deployment is a critical step toward embedding advanced robotic surgery within Singapore’s healthcare ecosystem and expanding its influence throughout the Asia-Pacific.

Vertical Integration and In-House Innovation: Cornerstones of Sustainable Growth

Cornerstone Robotics’ competitive edge stems from its comprehensive in-house research and development and vertically integrated manufacturing approach. The company has developed a robust technology platform encompassing mechanical engineering, electronics, software, algorithms, and vision imaging. This autonomy not only ensures superior clinical performance and system reliability but also enhances supply chain resilience and accelerates innovation cycles. The Sentire® Surgical System’s consistent stability and precision in complex surgical environments are direct outcomes of this integrated development model.

Leadership Perspective and Future Outlook

Professor Samuel Au, Founder and CEO of Cornerstone Robotics, remarked, “Securing both EU CE and Singapore HSA certifications is a pivotal achievement that transitions Cornerstone Robotics from a technology innovator to a global provider of clinical solutions. From our initial clinical trials in Portsmouth to obtaining multi-jurisdictional regulatory approvals, our journey reflects unwavering dedication to innovation, product excellence, and delivering tangible clinical benefits. Moving forward, we aim to deepen our presence in strategic markets and collaborate with leading medical institutions to extend the reach of advanced surgical robotics worldwide.”

The recent regulatory successes also coincide with a significant capital infusion. In November 2025, Cornerstone Robotics closed an oversubscribed funding round totaling approximately US$200 million, led by the Hong Kong Investment Corporation (HKIC) alongside global strategic investors and sovereign wealth funds. As a government-backed “patient capital” investor, HKIC’s support signals strong confidence in Cornerstone Robotics’ global commercialization strategy and long-term growth potential. Anchored by the European and Asia-Pacific markets, the company is poised to deliver increasingly precise and dependable robotic surgical solutions, enhancing patient care on a global scale.

About Cornerstone Robotics

Founded and nurtured in Hong Kong, Cornerstone Robotics (CSR) is a trailblazer in surgical robotics, dedicated to advancing medical innovation for improved global health outcomes. The company develops state-of-the-art robotic systems designed to make high-quality surgical care more accessible and efficient worldwide. With three international R&D centers and six business offices, CSR operates a 30,000-square-meter manufacturing facility in China. Its flagship Sentire® surgical system, developed entirely in-house, has completed extensive multi-specialty clinical trials and secured market approvals across China, the European Union, and Singapore, serving healthcare professionals and patients internationally.

For more information, visit https://en.csrbtx.com/