We are excited to share that Koh Young has received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its advanced neurosurgery robot, Geniant Cranial. This recent regulatory milestone follows the device’s U.S. FDA clearance in January 2025, marking a significant step forward in our international growth strategy.
Japan’s aging population is experiencing a rapid increase in brain diseases and degenerative neurological disorders, driving growing demand for minimally invasive neurosurgical procedures. Geniant Cranial is designed to meet this need by assisting neurosurgeons in performing precise, minimally invasive procedures for conditions including Parkinson’s disease, epilepsy, and brain tumors, integrating seamlessly into the operating room.
The growing demand is reflected in the market. According to Japan’s Ministry of Internal Affairs and Communications, the nation’s population aged 65 and over reached an all-time high of 36 million in 2024, accounting for 29.3% of the total population. The increasing prevalence of neurological conditions, coupled with government initiatives to improve neurological healthcare, is fueling adoption of innovative technologies that can enhance surgical precision, reduce procedure times, and improve patient outcomes.
Learn more about our PMDA approval 👉 Koh Young wins Japan PMDA nod for brain surgery robot, eye global push
See Geniant Cranial in person! We’ll be showcasing our technology at the 49th Annual Meeting of Epilepsy Surgery Society of Japan in Osaka, Japan | February 5-6, 2026.
👉 View our Upcoming Events