Cornerstone Robotics has received both a CE mark under the EU’s Medical Device Regulation (MDR) and Singapore Health Sciences Authority (HSA) certification for its Sentire® Endoscopic Surgical System, giving it regulatory access to Europe and Singapore as well as China.
These approvals cover minimally invasive procedures in General Surgery, Gynecology, Thoracic and Urology and mark a major step in the company’s global commercialization strategy.
Cornerstone has established a UK subsidiary and prior clinical and commercial presence in China and is now expanding into key markets in Europe and the Asia–Pacific region.
The Sentire system, developed in‑house, has completed multi‑specialty clinical trials and is part of a broader push to bring high‑quality robotic‑assisted surgery to more patients worldwide.
Sources:
Sentire® Surgical System Receives CE Mark (MDR) Approval ...
China's Cornerstone Robotics Raises RMB 800 Million for Surgical ...
Cornerstone Robotics secures $200M to take its surgical system ...
Articles from Cornerstone Robotics Limited | FinancialContent
Cornerstone Robotics' Sentire® Surgical System Gains CE Mark ...
El sistema quirúrgico Sentire® recibe la aprobación de la marca CE (MDR)
HONG KONG, July 17, 2025 - (ACN Newswire) - Cornerstone Robotics (CSR), a leading medical innovator
Cornerstone raises $200M to commercialize surgical robot