Cornerstone Robotics (CSR) has secured CE mark certification under the European Union’s Medical Device Regulation (MDR) for its Sentire® Endoscopic Surgical System, clearing the way for commercial use across Europe.
The approval covers a broad range of minimally invasive procedures, including general surgery, gynecology, thoracic, and urology.
The Sentire® system is designed as a fully integrated surgical robotics platform, combining advanced engineering, software, and imaging into a single clinical workflow. Earning CE certification confirms that the system meets Europe’s rigorous standards for safety, performance, and quality positioning it for wider global adoption.
CSR has already laid the groundwork for its European expansion, particularly in the UK. Since 2025, the company has been working with Portsmouth Hospitals University NHS Trust (PHU) to conduct clinical investigations of the system.
These efforts have generated valuable real-world data to support clinical validation, training development, and future adoption.
So far, the Sentire® system has been used in a range of complex procedures across urology, gynecology, and gastrointestinal surgery. The outcomes have met expectations, with clinicians reporting strong satisfaction with the system’s performance in real surgical settings.
From the outset, CSR has followed a “think global, act local” strategy. In Europe, this has translated into establishing a UK subsidiary and building a localized support model that includes training, clinical assistance, and after-sales service.
The company has already conducted multiple training programs, helping surgical teams quickly gain confidence and proficiency with the system – an important step toward scaling adoption.
A key part of CSR’s strategy is its full-stack, in-house R&D capability and vertically integrated model. This approach gives the company tighter control over technology development, supply chain stability, and system performance, while also allowing it to adapt quickly and continue innovating.
The CE mark represents a significant milestone in CSR’s global expansion plans. It follows a strong financial boost in November 2025, when the company raised around $200 million in an oversubscribed funding round signaling solid investor confidence in its long-term vision.
With regulatory approval secured and a growing international presence, Cornerstone Robotics is now well positioned to expand access to advanced, high-quality surgical robotics for healthcare providers and patients worldwide.
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