Japanese surgical robotics maker Medicaroid Corporation announced on July 10, 2026 that its hinotori Surgical Robot System has received CE marking under Europe's Medical Device Regulation, opening the door to a first European launch for the Kobe-based Kawasaki Heavy Industries and Sysmex joint venture. The approval covers procedures in urology, general surgery, gynecology and thoracic surgery, mirroring the specialties for which hinotori is already cleared in Japan.
Six years from Japan to EMEA
Medicaroid became Japan's first domestic maker to secure regulatory approval for a robotic-assisted surgery platform in 2020, positioning hinotori as a homegrown challenger to Intuitive Surgical's da Vinci system. The system has since won approvals in Singapore, Malaysia and, in June, Vietnam. Roughly 20,000 procedures have been performed globally with the robot to date, according to the company.
Europe was in the plan from day one
Medicaroid established Medicaroid Europe GmbH in Dusseldorf back in 2020 and filed the CE-MDR dossier in March 2025. The company will now begin an EMEA rollout from that German base. "Entry into the European market represents a significant milestone for Medicaroid in continuing to contribute to global healthcare through medical robots," the company said. A US market strategy remains under evaluation.
Kawasaki doubles down on medical robotics
The CE mark caps a run of medical-robotics investment by Kawasaki Heavy Industries, which in May opened a Japan-US development hub in San Jose in partnership with NVIDIA, Analog Devices, Microsoft and Fujitsu, with the hinotori platform among its initial focus areas. Kawasaki is also collaborating with IRCAD, the French surgical education institute, on training and clinical validation, echoing a broader push by robotic surgery vendors to marry AI with the operating room that also underpinned J&J's OTTAVA FDA authorization the same week.
Reporting based on coverage from MedTech Dive, MassDevice and Medicaroid's own release.