Cornerstone Robotics’ (CSR) Sentire endoscopic surgical system has secured approval under the EU Medical Device Regulation with the CE mark, as well as a separate certification from Singapore Health Sciences Authority (HSA).
These regulatory approvals allow the surgical robotic system to be used for minimally invasive operations in general surgery, gynaecology, thoracic surgery, and urology across both European and Asia-Pacific markets.
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The system is described as a high-end surgical robotic platform incorporating software, engineering and imaging technologies.
The CE certification confirms compliance with regulatory standards for safety, efficacy, and quality management.
According to the company, this positions the system to support healthcare professionals and patients in multiple regions.
CSR established early collaboration in the UK, partnering with Portsmouth Hospitals University NHS Trust since 2025 to perform a clinical investigation of the Sentire Surgical System.
The clinical study has generated real-world data to assist both research and training initiatives.
The company reports that the system has been used for a range of complex procedures in the UK, including in urology, gynaecology, and gastrointestinal surgery, with favourable outcomes and clinician satisfaction.
Outside Europe, the Singapore HSA approval provides access to another mature regulatory framework.
In April 2026, CSR installed the system at Woodlands Hospital under the National Healthcare Group, where it has been made available to medical teams from various hospitals for system testing, training, and workflow assessment.
Cornerstone Robotics founder and CEO Samuel Au said: “From our first clinical investigation in Portsmouth, UK, to achieving European regulatory approval, each 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 high-quality surgical robotic solutions to more physicians and patients worldwide.”
The company completed an oversubscribed financing round in November 2025, raising roughly $200m to support ongoing expansion.
