Hong Kong-based Cornerstone Robotics (CSR) said its Sentire Endoscopic Surgical System has received European Union CE mark certification under the Medical Device Regulation (MDR), the company announced on May 26, 2026. The approval covers minimally invasive procedures across general surgery, gynecology, thoracic surgery and urology, formally opening European markets to the platform.
Regulatory approval backed by clinical data
CSR describes Sentire as a high-end surgical robotic platform that integrates clinical workflows with engineering, software and imaging technologies. Achieving CE certification confirms that the system's safety, efficacy and quality-management processes meet European regulatory standards.
The company built an early presence in the United Kingdom, partnering since 2025 with Portsmouth Hospitals University NHS Trust to run a fully compliant clinical investigation. The system has completed numerous complex procedures there, spanning urology, gynecology and upper and lower gastrointestinal surgery.
Local services for a global push
CSR established a UK subsidiary in 2025 to provide training, clinical technical support and after-sales service, and has already run multiple training sessions to build clinician proficiency. "Receiving CE Certification marks a major milestone in Cornerstone Robotics' evolution from a technology innovator to a global clinical solutions provider," said Professor Samuel Au, the company's Founder and CEO.
Funding fuels expansion
The approval follows an oversubscribed financing round of roughly 200 million US dollars completed in late 2025. With three global R&D hubs, six business centers and a 30,000-square-meter manufacturing facility in China, CSR says Sentire has now secured market approval across China, the European Union and Singapore. The certification places Sentire among a growing field of newly approved systems, alongside milestones such as Sentante's CE-marked endovascular surgical robot, clinical-AI clearances including Bayesian Health's AI sepsis monitor, and medtech consolidation like Medtronic's acquisition of SPR Therapeutics.
Reporting based on coverage from AI Insider and PR Newswire.