Story Highlight
– Sentire(R) Surgical System receives EU CE and Singapore HSA certification.
– Approval boosts access to European and Asia-Pacific markets.
– Successful clinical investigations conducted in the UK since 2025.
– CSR expands global presence with localized training and support.
– Company secures $200 million financing for future growth.
Full Story
HONG KONG, 25 May 2026 — Cornerstone Robotics (CSR), a prominent innovator in the field of surgical robotics headquartered in Hong Kong, has announced the successful attainment of European Union CE mark certification and Singapore Health Sciences Authority (HSA) certification for its Sentire® Endoscopic Surgical System. This dual certification allows the Sentire® Surgical System to be deployed in minimally invasive surgical procedures across various medical branches, including General Surgery, Gynecology, Thoracic Surgery, and Urology, effectively granting it market access in both Europe and the Asia-Pacific region.
The Sentire® Surgical System is a sophisticated surgical robotic platform that harmoniously integrates clinical workflows with advanced engineering, software, and imaging technologies. Securing CE certification is a testament to the system’s compliance with rigorous safety and quality standards as dictated by the Medical Device Regulation (MDR). This pivotal certification underscores CSR’s commitment to delivering high-quality solutions to healthcare professionals and patients globally.
CSR has been making strides in the UK market since 2025, commencing a partnership with Portsmouth Hospitals University NHS Trust (PHU) to conduct a comprehensive clinical investigation into the capabilities of the Sentire® Surgical System. This initiative aims to compile real-world clinical data essential for evidence-based research, as well as to develop training protocols and facilitate the clinical adoption of the system. Since the initiation of this investigation, numerous complex surgeries have been performed in the UK using the Sentire® Surgical System, yielding favourable patient outcomes and receiving positive feedback from clinicians regarding the system’s operational efficiency.
The achievement of HSA certification in Singapore complements the EU CE certification, with Singapore having a reputation for its stringent safety and efficacy evaluations within its medical device market. The simultaneous receipt of these certifications affirms Cornerstone Robotics’ adherence to high standards of quality and compliance across diverse global regulations, enhancing the company’s credibility as a trusted provider of innovative surgical solutions.
Central to Cornerstone Robotics’ mission is a commitment to a ‘think global, act local’ strategy, which empowers the firm to engage with local medical professionals and patients effectively. Establishing its UK subsidiary in 2025 allowed CSR to offer a comprehensive suite of services, including professional training, technical support, and after-sales service concerning the Sentire® Surgical System. The company has already facilitated multiple training sessions, equipping clinical teams with the necessary skills and confidence to operate the system effectively as it prepares for a broader commercial rollout.
In tandem with its expansion in Europe, CSR has also broadened its collaborative efforts in the Asia-Pacific region. The company recently entered into a Memorandum of Understanding with the National Healthcare Group (NHG) and the Lee Kong Chian School of Medicine at Nanyang Technological University in Singapore. This trifold agreement aims to foster the growth of Singapore’s healthcare innovation ecosystem. Additionally, in April 2026, CSR successfully installed the Sentire® Surgical System at Woodlands Hospital under the auspices of NHG. This installation enables surgical teams from various local hospitals to test the system, train on its operations, and assess clinical workflows, thus propelling the implementation of cutting-edge surgical robotic technologies throughout Singapore and the broader Asia-Pacific market.
The company’s strategic advantage is significantly bolstered by its comprehensive in-house research and development (R&D) capabilities and vertical integration model. This structure fosters robustness in clinical performance, supply chain resilience, and operational stability, while simultaneously enhancing innovation and agility. Professor Samuel Au, the Founder and CEO of Cornerstone Robotics, articulated the significance of these certifications, stating: “Receiving EU CE and Singapore HSA certifications marks a major milestone in Cornerstone Robotics’ evolution from a technology innovator to a global clinical solutions provider. From our first clinical investigation in Portsmouth, UK, to achieving European regulatory approval, each step of the journey reflects our commitment to proprietary innovation, product excellence, and clinical value. Looking ahead, we will continue expanding into key global markets and partnering with leading medical institutions to bring high-quality surgical robotic solutions to more physicians and patients worldwide.”
The recent acquisition of both the EU CE and Singapore HSA certifications not only facilitates market access for the Sentire® Surgical System in Europe and Asia-Pacific but also signifies a considerable advancement in Cornerstone Robotics’ international growth trajectory. The company’s successful completion of an oversubscribed financing round of approximately US$200 million in November 2025 further reinforces investor confidence in its potential for long-term growth and its capabilities in global commercialisation.
With a focus on proprietary technology innovation and strategic resource allocation, Cornerstone Robotics is well-positioned to expedite the global integration of top-quality, readily accessible surgical robotic solutions for healthcare providers and patients alike.
Cornerstone Robotics is dedicated to leading advancements in surgical robotics aimed at creating a healthier world. Its cutting-edge systems are designed to enhance the quality of healthcare delivered globally. The company operates across three research and development hubs and six business locations worldwide, backed by an extensive 30,000 square metre manufacturing facility in China. The Sentire® Surgical System has successfully navigated clinical trials across multiple specialties and garnered market approval in China, the European Union, and Singapore, thereby contributing to the enhancement of surgical care on a global scale.
Our Thoughts
The article does not present any safety incidents or breaches related to the Sentire® Surgical System by Cornerstone Robotics. However, in a hypothetical scenario where issues arose during clinical investigations or system training, several key safety lessons could be highlighted.
To avoid potential risks, more robust training protocols and safety measures should be strictly enforced, following the Health and Safety at Work Act 1974, which mandates that employers ensure, as far as reasonably practicable, the health and safety of employees. Additionally, the Medical Devices Regulations (MDR) 2002, which govern the clinical use of medical devices in the UK, emphasize the importance of maintaining device safety and compliance through proper evaluation and monitoring.
Regular audits, comprehensive risk assessments, and effective incident reporting systems could enhance safety standards further. Moreover, implementing thorough pre-deployment testing and feedback loops from clinical teams can ensure continuous improvement in device operations and training. Such measures would minimize the risk of incidents and promote a culture of safety in surgical settings.
