Cornerstone Robotics’ Sentire Surgical System Secures EU CE Mark and Singapore HSA Approval

HONG KONG, May 27, 2026 – Hong Kong-based surgical robotics company Cornerstone Robotics has received European Union CE mark certification under the Medical Device Regulation (MDR) and approval from Singapore’s Health Sciences Authority (HSA) for its proprietary Sentire® Surgical System, marking a significant milestone in the company’s global expansion strategy.

The approvals cover minimally invasive procedures across general surgery, gynecology, thoracic surgery and urology, enabling the Sentire® Surgical System to formally enter key medical markets in Europe and Asia-Pacific.

Cornerstone Robotics said it has become the first Hong Kong-based surgical robotics brand to simultaneously achieve EU regulatory certification and extensive European clinical validation.

The Sentire® platform integrates engineering, imaging, software and clinical workflow technologies into a high-end robotic surgical system designed to support minimally invasive procedures. Alongside regulatory approvals, the company has also been advancing clinical validation efforts through partnerships in Europe, including a collaboration with Portsmouth Hospitals University NHS Trust in the United Kingdom.

Since 2025, the system has reportedly completed numerous complex procedures across specialties such as urology, gynecology and gastrointestinal surgery in the UK, generating positive patient outcomes and clinician feedback.

The company has also expanded its localisation and training efforts in Europe by establishing a UK subsidiary that provides surgeon training, clinical technical support and after-sales services.

In Singapore, Cornerstone Robotics previously signed a tripartite memorandum of understanding with the National Healthcare Group and the Nanyang Technological University’s Lee Kong Chian School of Medicine to support healthcare innovation initiatives.

In April 2026, the company completed the first installation of the Sentire® Surgical System at Woodlands Hospital in Singapore under NHG, where it is currently being used for training, workflow adaptation assessments and system evaluation by surgical teams from multiple hospitals.

Cornerstone Robotics said its long-term strategy centres on full-stack in-house research and development and vertical integration across mechanical, electrical, imaging, algorithmic and software technologies.

Samuel Au, Founder and CEO of Cornerstone Robotics, said the dual regulatory approvals mark a major transition point for the company. “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,” Au said.

The company also recently completed an oversubscribed financing round of approximately US$200 million led by the Hong Kong Investment Corporation, alongside sovereign funds and global strategic investors.

Cornerstone Robotics currently operates three global R&D centres, six business centres worldwide and a 30,000-square-metre manufacturing facility in China.