Koh Young Technology (hereafter Koh Young) said on the 20th that its Geniant Cranial, a medical robot for brain surgery, has obtained approval from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. With this approval, Koh Young can now officially sell the robot in Japan, a global advanced medical device market.
Geniant Cranial obtained U.S. Food and Drug Administration (FDA) 510(k) clearance in Jan. 2025 and went on to secure approval in Japan from the PMDA, which applies stringent review standards, as a high-risk (Class III) medical device.
In particular, Koh Young became the first domestic robotics company in the brain surgery field to secure approvals from both the U.S. FDA and Japan's PMDA. Based on this, the company plans to fully roll out its global medical robot business and target overseas markets.
Japan is seeing a rapid increase in brain diseases and degenerative neurological disorders as it enters a super-aged society, and demand is steadily growing for minimally invasive brain surgery that can enhance precision while reducing the burden on patients. Japan also has about 1,700 neurosurgical hospitals capable of performing brain surgery nationwide, making it a market considered to be large in scale.
A Koh Young official said, "In Japan, demand for precision robotic surgery and interest among medical staff are high, so inquiries about adoption have continued from leading neurosurgery faculty members even before approval," adding, "Through our Japanese subsidiary, we will quickly promote cooperation with major hospitals and initial installations to fully expand the surgical robot business in Japan."
Meanwhile, Geniant Cranial is used across various neurosurgical areas, including movement disorders such as epilepsy and Parkinson's disease, and brain tumor tissue biopsies. Its surgical guide robot and navigation support precise registration and real-time tracking, providing medical staff with a precise and intuitive surgical environment.
According to Transparency Market Research, the global surgical robot market is projected to grow by an average of 11% annually to reach $20.8 billion (about 30 trillion won) by 2031. With advances in robotic technology and rising demand for precision medicine, robotic surgery is rapidly spreading across fields such as neurosurgery, orthopedics, and general surgery.