Cornerstone Robotics (CSR), a Hong Kong-based surgical robotics innovator, has announced that its Sentire(R) Endoscopic Surgical System has secured both European Union CE mark certification under the Medical Device Regulation (MDR) and approval from Singapore’s Health Sciences Authority (HSA). 

The certifications cover minimally invasive procedures across general surgery, gynecology, thoracic surgery, and urology, paving the way for the system’s commercial entry into European and Asia-Pacific markets.

The Sentire(R) Surgical System is an advanced robotic surgical platform integrating engineering, software, imaging technologies, and clinical workflows. The CE certification validates the system’s compliance with stringent European standards for safety, efficacy, and quality management, positioning it for broader international adoption.

CSR has been actively expanding its clinical footprint in the UK. Since 2025, the company has collaborated with Portsmouth Hospitals University NHS Trust to conduct clinical investigations of the Sentire(R) Surgical System. 

The program has generated real-world clinical data across specialties including urology, gynecology, and gastrointestinal surgery, with clinicians reporting strong satisfaction with the system’s performance and patient outcomes.

The simultaneous approval from Singapore’s HSA further highlights the company’s ability to meet multiple global regulatory standards. Singapore is widely regarded as one of the Asia-Pacific region’s most rigorous and mature medical device regulatory markets.

Samuel Au, Founder and CEO of Cornerstone Robotics, said the dual approvals mark a major step in the company’s transition from a technology innovator to a global clinical solutions provider.