Hong Kong, China – May 25, 2026
Cornerstone Robotics (CSR) announced that its Sentire® Endoscopic Surgical System has officially received both European Union CE Mark certification under the Medical Device Regulation (MDR) and Singapore Health Sciences Authority (HSA) certification, marking a major global milestone for the company’s advanced robotic-assisted surgery platform. The dual regulatory approvals cover minimally invasive procedures across General Surgery, Gynecology, Thoracic Surgery, and Urology, enabling the Sentire® Surgical System to enter both European and Asia-Pacific healthcare markets. Industry experts view the achievement as a significant advancement in the rapidly growing global surgical robotics sector and an important validation of the system’s clinical safety, performance, and regulatory compliance standards.
The Sentire® Surgical System is a next-generation robotic-assisted surgery platform integrating advanced engineering, software systems, imaging technologies, and clinical workflow optimization into a single surgical ecosystem. According to Cornerstone Robotics, the dual certifications confirm that the system meets stringent international standards for medical device safety, efficacy, quality management, and clinical performance. The company stated that the approvals represent a critical step in its broader international commercialization strategy focused on expanding access to minimally invasive robotic surgery worldwide.
Sentire® Surgical System Expands Global Surgical Robotics Presence
The CE Mark certification under the European Union MDR framework is considered one of the most rigorous medical device regulatory pathways globally and serves as a major benchmark for advanced healthcare technologies entering European markets. Industry analysts note that MDR compliance requirements are significantly stricter than previous European regulatory standards, emphasizing clinical evidence, post-market surveillance, risk management, and long-term device performance.
Cornerstone Robotics revealed that it has already established an operational presence in the United Kingdom through its partnership with Portsmouth Hospitals University NHS Trust (PHU). Since 2025, the company has conducted fully compliant clinical investigations involving the Sentire® Surgical System to generate real-world clinical data supporting evidence-based surgical training, workflow optimization, and future commercial deployment strategies.
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According to the company, the system has already completed multiple complex robotic-assisted procedures in the UK across specialties including urology, gynecology, and upper and lower gastrointestinal surgery. Clinical investigators involved in the studies reported positive patient outcomes and high physician satisfaction with the platform’s overall performance, precision, and usability during minimally invasive procedures.
Simultaneously, the Singapore HSA certification further strengthens Cornerstone Robotics’ access to one of Asia-Pacific’s most advanced and internationally recognized medical device regulatory environments. Analysts believe dual approvals from both the EU and Singapore significantly increase confidence in the platform’s global regulatory readiness and commercial scalability.
Cornerstone Robotics Accelerates Asia-Pacific Expansion
Cornerstone Robotics stated that it continues implementing its “think global, act local” strategy through localized physician partnerships, surgical training programs, and regional healthcare collaborations. In Singapore, the company previously signed a tripartite Memorandum of Understanding with the National Healthcare Group (NHG) and the Lee Kong Chian School of Medicine at Nanyang Technological University to support development of healthcare innovation and robotic surgery capabilities in the region.
Earlier this year, the company completed the first installation of the Sentire® Surgical System at Woodlands Hospital in Singapore, where the platform is currently being utilized for surgical team training, workflow adaptation assessments, and clinical testing. The deployment is intended to support broader robotic-assisted surgery adoption across Singapore and neighboring Asia-Pacific healthcare systems.
Company leadership emphasized that its vertically integrated development strategy and full-stack in-house research and development capabilities remain central to the Sentire® platform’s scalability and innovation. The company stated that tight integration between hardware, software, imaging systems, and clinical applications improves operational stability, supply chain resilience, technological flexibility, and long-term innovation potential.
Surgical Robotics Industry Continues Rapid Growth Worldwide
The global robotic-assisted surgery market continues expanding rapidly as hospitals increasingly adopt minimally invasive surgical systems designed to improve precision, reduce recovery times, minimize surgical trauma, and enhance procedural outcomes. Industry experts expect continued growth in robotic surgery across urology, gynecology, thoracic surgery, colorectal surgery, and general surgery applications over the coming decade.
Cornerstone Robotics also highlighted that its recent oversubscribed financing round of approximately US$200 million demonstrates strong investor confidence in the company’s long-term growth strategy and international commercialization potential. Analysts believe the company is positioning itself as an emerging competitor within the global surgical robotics industry through regulatory expansion, clinical validation, and technological innovation.
As healthcare providers worldwide continue modernizing surgical infrastructure through robotic-assisted technologies, the Sentire® Surgical System’s dual regulatory certifications represent another important step toward broader adoption of advanced minimally invasive surgery platforms designed to improve clinical efficiency, physician performance, and patient care outcomes globally.
Source: Cornerstone Robotics press release
