HONG KONG, May 26, 2026 - (ACN Newswire) - Cornerstone Robotics, a leading innovator in surgical robotics based in Hong Kong, is pleased to announce that its proprietary Sentire(R) Surgical System has officially received European Union CE mark certification under the Medical Device Regulation (MDR) and has simultaneously obtained approval from the Health Sciences Authority (HSA) of Singapore. These certifications cover minimally invasive surgical procedures in General Surgery, Gynecology, Thoracic and Urology. This milestone marks the formal entry of the Sentire(R) Surgical System into the core medical markets of Europe and the Asia-Pacific. Cornerstone Robotics has thus become the first Hong Kong-based surgical robotics brand to simultaneously complete EU regulatory certification and in-depth European clinical validation, signaling that Hong Kong’s high-quality medical device innovation has officially entered the international market’s main track.
Achieving Combined Regulatory Approval and Clinical Validation
The Sentire(R) Surgical System is a high-end surgical robotic platform that combines clinical workflows with integrated engineering, software, and imaging technologies. Achieving CE certification not only demonstrates that its safety, efficacy, and quality management system fully comply with stringent international regulatory standards but also affirms that this high-quality platform possesses the robust capability and credentials to serve physicians and patients worldwide.
Alongside regulatory certification, Cornerstone Robotics has simultaneously advanced its international clinical validation. By leveraging its three global R&D centres and establishing an early presence in the UK, the Company has integrated European talent and clinical resources to inject international innovation momentum into product iteration and clinical adaptation. Since 2025, the Company has partnered with Portsmouth Hospitals University NHS Trust (PHU) to undertake a fully compliant clinical investigation for the Sentire(R) Surgical System, steadily accumulating real-world European clinical data to support evidence-based research, training protocol development, and clinical adoption. To date, the Sentire(R) Surgical System has successfully completed numerous complex procedures in the UK, spanning core specialties including urology, gynecology, and upper and lower gastrointestinal surgery. The investigation achieved positive patient outcomes, and the clinicians were very satisfied with the system’s performance.
Concurrently, the Singapore HSA certification, as one of the highly mature and internationally recognised medical device market access systems in the Asia-Pacific, is similarly renowned for its rigorous safety and efficacy evaluations. The Sentire(R) Surgical System's simultaneous achievement of certifications from both the EU and Singapore fully demonstrates Cornerstone Robotics' quality and compliance across different global regulatory frameworks.
Deepening Global Presence with One-Stop Localised Services
Adhering to its “From Hong Kong to the World” strategy, Cornerstone Robotics has deepened its global localisation efforts with the strategic support of the Hong Kong Investment Corporation (the HKIC), aiming to empower physicians and patients worldwide through professional service. In the European market, to further support regional customers and enhance clinical responsiveness, the Company established its UK subsidiary in 2025, initiating a one-stop service provision encompassing professional training, clinical technical support, and after-sales service. The Company has already completed multiple training sessions in the UK, covering surgeons, operating room nursing teams, and hospital technical support personnel, helping clinical teams rapidly build proficiency and confidence in operating the Sentire(R) Surgical System, thereby establishing a solid foundation for scaled commercial rollout.
While continuing to deepen its European footprint, Cornerstone Robotics has also been actively expanding its Asia-Pacific collaboration network. Previously, Cornerstone Robotics signed a tripartite Memorandum of Understanding (MOU) with the National Healthcare Group (NHG) and the Lee Kong Chian School of Medicine (LKC Medicine) of Nanyang Technological University, Singapore, to jointly advance the development of Singapore's healthcare innovation ecosystem. In April 2026, Cornerstone Robotics completed the first installation of the Sentire(R) Surgical System in Singapore at Woodlands Hospital under NHG. The system is being made available to surgical teams from multiple local hospitals for system testing, operation training and clinical workflow adaptation assessments. This deployment leverages the system’s performance in research and training, steadily advancing the adoption of innovative surgical robotic applications in Singapore and the broader Asia-Pacific region.
Full-Stack In-House R&D and Vertical Integration: The Foundation for High-Quality Global Expansion
Cornerstone Robotics has consistently adhered to the long-term strategy of full-stack in-house R&D and vertical integration, which forms the foundation of its competitive advantage and high-quality international expansion. Anchored in this strategy, the Company has successfully built an underlying technology platform spanning mechanical, electrical, software, algorithmic, and vision imaging technologies. This high degree of technological autonomy ensures superior clinical performance, secures supply chain resilience, and enhances the agility and long-term innovation potential of its R&D. Built upon this vertically integrated architecture, the Sentire(R) Surgical System delivers exceptional stability and predictable performance in demanding surgical environments.
Professor Samuel Au, Founder and CEO of Cornerstone Robotics, commented: “Receiving both EU CE and Singapore HSA certifications marks a major milestone in Cornerstone Robotics' evolution from technology innovator to a global clinical solution provider. From our first clinical investigation in Portsmouth, UK, to formally securing multi-jurisdictional regulatory approvals, every 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 advanced surgical robotic solutions to more physicians and patients worldwide.”
The successive approvals of both EU CE and Singapore HSA certifications represent not only important market access gateways for the Sentire(R) Surgical System, but also a signal that Cornerstone Robotics' globalisation strategy has entered an accelerated phase. Strategic capital support has injected further momentum into this global push. In November 2025, Cornerstone Robotics successfully completed an oversubscribed financing round of approximately US$200 million, led by the HKIC with participation of global strategic investors and top-tier sovereign funds. As a flagship “patient capital” investor wholly owned by the HKSAR Government, the HKIC’s investment underscores market confidence in Cornerstone Robotics' global commercial capabilities and long-term growth prospects. With the European and Asia-Pacific markets as strategic anchors, Cornerstone Robotics is delivering more precise and reliable robotic solutions to physicians worldwide and extending higher-quality life protection to patients across the globe.
About Cornerstone Robotics (CSR)
Established and incubated in Hong Kong, Cornerstone Robotics (CSR) is an innovative surgical robotics unicorn driven by the vision of leading medical innovations for a healthier world. It advances surgical care with cutting-edge robotic systems that make high-quality healthcare more accessible and efficient globally. With three global R&D hubs and six business centers worldwide, the company has established a 30,000-square-meter manufacturing facility in China. Developed entirely in-house, its Sentire(R) surgical system has successfully completed multi-specialty clinical trials and received market approval in multiple countries and regions, including China, the European Union and Singapore, serving medical professionals globally and bringing better care to more patients.
To find out more information, please visit our website at https://en.csrbtx.com/