The CE approval opens Europe for Cornerstone Robotics as the company expands its global surgical robotics business
Updated
May 29, 2026 4:20 AM
A tray of surgical tools. PHOTO: UNSPLASH
As surgical robotics companies expand beyond domestic markets, regulatory approvals are becoming a critical part of global growth. Companies are no longer competing only on hardware and clinical performance. They are also competing on their ability to enter tightly regulated healthcare systems and build long-term hospital partnerships.
Hong Kong-based Cornerstone Robotics is now moving further into that phase of expansion after its Sentire Endoscopic Surgical System received CE Mark certification under the European Union’s Medical Device Regulation framework.
The approval allows the company to commercialize the system across European markets for minimally invasive procedures in general surgery, gynecology, thoracic surgery and urology. For surgical robotics companies, regulatory approvals often represent more than product validation. They also determine market access, hospital adoption opportunities and long-term commercial scale.
Cornerstone Robotics has already been building clinical operations in the UK ahead of the approval. Since 2025, the company has worked with Portsmouth Hospitals University NHS Trust on clinical investigations involving the Sentire Surgical System. According to the company, the system has been used across procedures involving urology, gynecology and gastrointestinal surgery. The company says the clinical investigation helped generate real-world data to support physician training, research and future adoption efforts.
Alongside the regulatory approval, Cornerstone Robotics is also expanding its local operations in Europe. The company established a UK subsidiary in 2025 and has been developing training, clinical support and after-sales service capabilities for hospitals using the system.
That operational buildout reflects a larger challenge inside surgical robotics. Hospitals adopting robotic systems often require ongoing clinical training, technical support and workflow integration alongside the hardware itself.
Cornerstone Robotics says its strategy centers around vertically integrated development across engineering, software, imaging and robotics systems. The company argues that this structure gives it greater control over product development, supply chain management and long-term operational stability.
Professor Samuel Au, Founder and CEO of Cornerstone Robotics, said: "Receiving CE Certification marks a major milestone in Cornerstone Robotics' evolution from a technology innovator to a global clinical solutions provider. 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 CE approval also comes several months after the company completed an oversubscribed financing round of approximately US$200 million in November 2025.
The funding and regulatory expansion together signal how surgical robotics companies are increasingly entering a more commercially focused stage of growth. Beyond research and development, companies are now investing more heavily in regulatory approvals, hospital partnerships, physician training and international operational infrastructure as competition expands across global healthcare markets.
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A closer look at how machine intelligence is helping doctors see cancer in an entirely new light.
Updated
January 8, 2026 6:33 PM
Serratia marcescens colonies on BTB agar medium. PHOTO: UNSPLASH
Artificial intelligence is beginning to change how scientists understand cancer at the cellular level. In a new collaboration, Bio-Techne Corporation, a global life sciences tools provider, and Nucleai, an AI company specializing in spatial biology for precision medicine, have unveiled data from the SECOMBIT clinical trial that could reshape how doctors predict cancer treatment outcomes. The results, presented at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting, highlight how AI-powered analysis of tumor environments can reveal which patients are more likely to benefit from specific therapies.
Led in collaboration with Professor Paolo Ascierto of the University of Napoli Federico II and Istituto Nazionale Tumori IRCCS Fondazione Pascale, the study explores how spatial biology — the science of mapping where and how cells interact within tissue — can uncover subtle immune behaviors linked to survival in melanoma patients.
Using Bio-Techne’s COMET platform and a 28-plex multiplex immunofluorescence panel, researchers analyzed 42 pre-treatment biopsies from patients with metastatic melanoma, an advanced stage of skin cancer. Nucleai’s multimodal AI platform integrated these imaging results with pathology and clinical data to trace patterns of immune cell interactions inside tumors.
The findings revealed that therapy sequencing significantly influences immune activity and patient outcomes. Patients who received targeted therapy followed by immunotherapy showed stronger immune activation, marked by higher levels of PD-L1+ CD8 T-cells and ICOS+ CD4 T-cells. Those who began with immunotherapy benefited most when PD-1+ CD8 T-cells engaged closely with PD-L1+ CD4 T-cells along the tumor’s invasive edge. Meanwhile, in patients alternating between targeted and immune treatments, beneficial antigen-presenting cell (APC) and T-cell interactions appeared near tumor margins, whereas macrophage activity in the outer tumor environment pointed to poorer prognosis.
“This study exemplifies how our innovative spatial imaging and analysis workflow can be applied broadly to clinical research to ultimately transform clinical decision-making in immuno-oncology”, said Matt McManus, President of the Diagnostics and Spatial Biology Segment at Bio-Techne.
The collaboration between the two companies underscores how AI and high-plex imaging together can help decode complex biological systems. As Avi Veidman, CEO of Nucleai, explained, “Our multimodal spatial operating system enables integration of high-plex imaging, data and clinical information to identify predictive biomarkers in clinical settings. This collaboration shows how precision medicine products can become more accurate, explainable and differentiated when powered by high-plex spatial proteomics – not limited by low-plex or H&E data alone”.
Dr. Ascierto described the SECOMBIT trial as “a milestone in demonstrating the possible predictive power of spatial biomarkers in patients enrolled in a clinical study”.
The study’s broader message is clear: understanding where immune cells are and how they interact inside a tumor could become just as important as knowing what they are. As AI continues to map these microscopic landscapes, oncology may move closer to genuinely personalized treatment — one patient, and one immune network, at a time.