Medicaroid Corporation obtained CE marking under the EU Medical Device Regulation (MDR 2017/745) for its hinotori surgical robot system, announced on July 10, 20261,2. The approval enables the Kobe-based company to market the system in EU member states and certain non-EU countries, opening a path to commercial launch in a European surgical robotics market long dominated by Intuitive Surgical's da Vinci platform.
The CE mark covers procedures across urology, general surgery, gynaecology, and thoracic surgery. Medicaroid filed for the certification in March 2025.
Medicaroid is a joint venture between Kawasaki Heavy Industries and Sysmex. The company became the first Japanese domestic manufacturer to secure regulatory approval for a robotic surgery system in Japan in 2020. Since then, hinotori has received regulatory approvals in Singapore in 2023, Malaysia in 2024, and Vietnam. Approximately 20,000 procedures have been performed globally with the system to date.
To support its European expansion, Medicaroid established Medicaroid Europe GmbH in Germany in 2020 as a base of operations. Intuitive Surgical has publicly identified Medicaroid as one of its competitors.
The AI-relevant dimension of the hinotori platform centers on a development hub that parent company Kawasaki Heavy Industries opened in San Jose in May 2026, built in collaboration with Nvidia, Analog Devices, Microsoft, and Fujitsu. The hub has an initial focus on healthcare applications including hinotori. Kawasaki Heavy Industries has also partnered with French surgical education institute IRCAD to support clinician training.
Medicaroid continues to evaluate the US market opportunity but has not yet filed for FDA clearance.
ANALYSIS The Nvidia, Microsoft, Analog Devices, and Fujitsu collaboration at the San Jose hub signals that Kawasaki Heavy Industries is investing in AI and advanced computing capabilities around the hinotori platform, potentially differentiating it from incumbents through software and intelligence layers rather than hardware alone. The CE mark gives Medicaroid a regulatory foothold in Europe just as this AI-oriented development effort ramps up, linking the company's market access timeline to its technology roadmap.