New surgical robots in Europe: hinotori receives the CE mark, following da Vinci 5 and Sentire

What happened

Kobe-based Medicaroid announced on 9 July 2026 that its hinotori surgical robot system had obtained the CE mark under the EU Medical Device Regulation (MDR 2017/745). This allows the company to market it in EU member states and some non-EU countries. The robot has been approved in Japan since 2020, then in Singapore (2023), Malaysia (2024) and Vietnam (2026). For the European market, the company set up a subsidiary in Germany in 2020.

Other systems recently approved in Europe

• da Vinci 5 (Intuitive, 2 July 2025): the fifth generation of the da Vinci system received the CE mark for adults and children in urological, gynaecological, general laparoscopic and thoracoscopic procedures. The maker cites more than 150 enhancements, including Force Feedback technology. Da Vinci systems were used in more than 410,000 procedures in Europe in 2024.
• Versius for children (CMR Surgical, 8 January 2026): the British company's modular robot received CE and UKCA marks for abdominal surgery in patients under 18, after a study of almost 150 procedures at three centres.
• Sentire (Cornerstone Robotics, 25 May 2026): the Hong Kong company's system received the CE mark under the MDR for general surgery, gynaecology, thoracic surgery and urology. In the UK it has been evaluated since 2025 in a clinical investigation with Portsmouth Hospitals University NHS Trust.

What it means for patients now

The CE mark allows a system to be marketed in the European Union; it does not mean it becomes immediately available in a given hospital. Each hospital decides what equipment to buy and trains its teams. More manufacturers may, over time, mean more options for hospitals. For patients, the relevant questions remain whether robotic surgery suits their case and how experienced the team is with the system used.

What is still unknown

The manufacturers' announcements contain no comparisons between systems on patient outcomes or costs. For some of the new systems, clinical experience in Europe is still limited, and data will come from hospital use and independent studies. It is also not yet known in which countries and hospitals the first units will be installed.