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
How a Korean biotech startup is using AI to move drug discovery from trial-and-error to precision design
A close up of a protein structure model. PHOTO: UNSPLASH
For decades, drug discovery has relied on trial and error, with scientists testing thousands of molecules to find one that works. Galux, a South Korean biotech startup, is changing that by using AI to design proteins from scratch. This method, called “de novo” design, makes it possible to build precise new therapies instead of searching through existing ones.
The company recently announced a US$29 million Series B funding round, bringing its total capital to US$47 million.This significant investment attracted a substantial roster of institutional backers, including the Korea Development Bank (KDB), Yuanta Investment, SL Investment and NCORE Ventures. These firms joined existing investors such as InterVest, DAYLI Partners and PATHWAY Investment, as well as new participants including SneakPeek Investments, Korea Investment & Securities and Mirae Asset Securities.
At the core of the company’s work is a platform called GaluxDesign. Unlike many AI tools that only predict how existing proteins fold, this system uses deep learning and physics to create entirely new therapeutic antibodies. This “from scratch” approach lets the team go after so-called “undruggable” proteins. These are targets that traditional small-molecule drugs can’t reach because they lack clear binding pockets. By designing proteins to fit these complex shapes, Galux aims to unlock treatments that have stayed out of reach for decades. And that’s exactly why investors are paying attention.
The pharmaceutical industry is actively looking for faster and more efficient ways to develop new drugs, and Galux is built for exactly that. The company connects its AI platform directly to its own wet lab, where designs can be tested in real time. Each result feeds straight back into the system, sharpening the next round of models. This continuous loop speeds up discovery and improves precision at every step. It’s also why partners like Celltrion, LG Chem and Boehringer Ingelheim are already working with Galux.
Galux is no longer just trying to make drugs that stick to a target. The company now wants its AI to design medicines that actually work in the body and can be made at scale. In simple terms, a drug has to do more than bind to a disease—it must be stable, safe and strong enough to change how the illness behaves. Galux is moving into tougher targets such as ion channels and GPCRs. These play key roles in heart function and sensory signals. Ultimately, the goal is to show that AI-driven design can turn complex biology into real treatments. And instead of hunting blindly for a solution, the team is building exactly what they need.