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.
Keep Reading
From AI diagnostics to exoskeletons, the event highlights how healthcare tech is moving into real-world use
Updated
May 1, 2026 2:25 PM
Tesla Bot Optimus, designed by Tesla. PHOTO: ADOBE STOCK
The China International Medical Equipment Fair 2026 will open in Shanghai from April 9 to 12 at the National Exhibition and Convention Center. It is one of the largest gatherings in the medical device industry. This year’s edition will cover more than 320,000 square metres. Nearly 5,000 companies and brands are expected to participate, representing over 20 countries and regions. Organisers also expect more than 200,000 professional visitors and buyers from around 150 markets.
A key focus this year is the growing use of artificial intelligence in healthcare. One of the headline technologies is an AI agent designed to carry out multiple diagnoses from a single scan. The exhibition will also feature diagnostic software that is already in clinical use. In addition, an integrated platform for AI training and inference will be showcased to improve computing capacity within healthcare institutions.
Robotics will also play a central role at the event. New systems across surgical procedures, rehabilitation and elderly care are expected to be presented. Together, these developments point to a steady move toward more precise and assisted forms of care. Many of these technologies are designed to support clinicians and patients, especially in tasks that require consistent accuracy or long-term physical assistance.
For the first time, the event will introduce a dedicated Future Tech Arena. It will focus on brain-computer interfaces, embodied intelligence and university-led innovation. The space will include AI-assisted MRI systems for Alzheimer’s diagnosis. It will also feature brain-computer interface technologies used for cognitive assessment and training, along with wearable robotic exoskeletons.
Alongside product showcases, the event will continue to act as a platform for international trade and collaboration. An International Zone will host exhibitors from countries such as the United States, Germany, Japan, South Korea, the United Kingdom, France, Singapore, Malaysia and Thailand. This provides a view of how different markets are approaching medical technology. It also reflects the global nature of innovation and deployment in this sector.
The programme will include a set of networking and exchange formats under its “We” initiative. These include discussion stages with representatives from consulates and industry organisations, as well as matchmaking sessions based on verified buyer demand. Guided tours will also be organised to help international visitors connect with relevant exhibitors. In parallel, organisers are working with hospital partners to provide medical support services for attendees during the event.
Across the four days, hundreds of forums are scheduled. These will bring together policymakers, researchers and industry leaders to discuss regulatory frameworks, market access and the future of healthcare innovation. Some of these sessions will be led by the Global Harmonization Working Party in collaboration with the Ministry of Health of Malaysia, with a focus on regulatory alignment and cross-border cooperation in medical devices.
As healthcare systems continue to adopt digital tools and advanced equipment, events like CMEF provide a clear view of how these technologies are being developed and applied. The scale of participation this year reflects continued activity across both innovation and international collaboration in the medical device sector.