Dive Brief:
- Medicaroid said this week it received the CE mark for its Hinotori surgical robot, a key step in the Kobe, Japan-based company’s expansion plans for Europe, the Middle East and Africa.
- A joint venture of Kawasaki Heavy Industries, a leader in industrial robotics, and diagnostic instruments maker Sysmex, Medicaroid in 2020 became the first domestic manufacturer to obtain regulatory approval for a robotic surgery system in Japan, setting it up to compete with market leader Intuitive Surgical.
- The CE mark gives Medicaroid’s robot authorization in Europe to perform procedures in urology, general surgery, gynecology and thoracic surgery, the same specialties it is approved for in Japan, the company told MedTech Dive in an email.
Dive Insight:
Medicaroid is among a list of companies that Intuitive has identified as bringing competition to the field of robot-assisted medical procedures.
Following its launch in Japan, the Hinotori system won regulatory approvals in Singapore in 2023, Malaysia in 2024 and more recently Vietnam. To date, about 20,000 procedures have been performed globally with the robot, Medicaroid said in its email.
As it pursued growth in the Asia-Pacific region, the company also laid the groundwork for expansion into Europe, the Middle East and Africa with the establishment of a base of operations in Germany in 2020. Medicaroid said in March 2025 that it filed for Europe’s CE mark certification.
“Entry into the European market represents a significant milestone for Medicaroid in continuing to contribute to global healthcare through medical robots,” the company said in a statement.
Medicaroid continues to evaluate the U.S. market opportunity, it said in an emailed response to a question from MedTech Dive.
In May, Kawasaki opened a development hub in San Jose, California, working with Nvidia, Analog Devices, Microsoft and Fujitsu to advance Japan-U.S. collaboration in the artificial intelligence and semiconductor fields. An initial focus will be on healthcare and nursing care and will include the Hinotori surgical robot.
Kawasaki is also partnering with IRCAD, a surgical education and research institute based in France.
