On Tuesday, ROEN Surgical, a surgical robot platform company, announced that it has received approval from South Korea’s Ministry of Food and Drug Safety for modifications to its artificial intelligence (AI)-powered kidney stone surgery robot, Zamenix, along with its suction-type ureteral dilator (FANS) and associated software.
This approval enables Zamenix to be used in conjunction with the Flexible and Navigable Suction Sheath (FANS), which can access stone locations and suction out fragmented stones. The suction feature allows for real-time removal of fine stone fragments, reducing residual stones and improving visibility during procedures.
Zamenix now incorporates advanced automated features utilizing robotic control technology. These include an automatic suction direction adjustment function that guides optimal suction by recognizing the robot-mounted endoscope, and a feature that automates the endoscope’s in-body extraction during suction. These innovations allow surgeons to perform suction procedures using only console controls.
Patient safety enhancements have also been implemented. ROEN Surgical reports that preliminary studies conducted from 2024 to 2025 demonstrated that combining Zamenix with FANS maintains kidney temperature and pressure below critical thresholds of 43°C (about 109.4°F) and 40 cmH₂O, respectively, even during continuous laser exposure.
These new capabilities can be added through software updates, eliminating the need for hardware replacement. Hospitals already using Zamenix can access the new suction techniques via free software upgrades, potentially improving operating room efficiency and equipment utilization.
Kwon Dong-soo, Chief Executive Officer (CEO) of ROEN Surgical, stated that through ongoing software updates, Zamenix will evolve into a platform that enhances surgical efficiency and cost-effectiveness for hospitals. They’re committed to developing features that reduce the burden on medical staff and improve patient safety, delivering operational innovations to hospitals both in the U.S. and globally.
Notably, Zamenix was designated as the 17th innovative medical device in South Korea in 2021. Following a multi-center clinical trial involving 232 participants, it received approval for clinical use of innovative medical technology from the National Evidence-based Healthcare Collaborating Agency (NECA) in May of this year. The system is currently in use at 20 hospitals in South Korea and one international facility.