Roen Surgical, a corporations in surgical robot platforms, said on the 1st that its artificial intelligence (AI)-based kidney stone surgery robot Zamenix received a modification approval from the Ministery of Food and Drug Safety (MFDS) to automatically assist surgery in linkage with a suction device that vacuums up stones.
With this approval, Zamenix can now link with the suction-type ureteral dilator (FANS) that approaches the stone location and suctions and expels the fragmented stone pieces. Beyond simply using a suction device, functions were added for the robot to automatically adjust the suction direction and control endoscope movement.
Using the suction function during kidney stone surgery allows real-time suction and expulsion of the fine stone powder fragmented by laser. It can help lower the risk of recurrence due to residual stones after surgery and help the medical team secure a clearer surgical field.
Through this upgrade, Zamenix is equipped with a host of automation features that combine robot control technology. Notably, the Auto Suction Orientation feature was added, which recognizes the position of the robot-mounted endoscope and guides the optimal suction direction.
The robot also controls the internal movement and extraction of the endoscope required during suction through autonomous driving. As a result, the operating surgeon can perform suction techniques with console operation alone, reducing reliance on surgical assistants, the company said.
Patient safety was also strengthened. Roen Surgical said that in a preliminary study conducted in 2024–2025, it confirmed that even with continuous laser irradiation while Zamenix and FANS were combined, the temperature and pressure inside the kidney were stably maintained below their respective thresholds of 43℃ and 40cmH2O.
The company said the results indicate the potential to reduce the risk of major complications such as tissue damage or urinary tract infection caused by heat and pressure that can occur during surgery.
Roen Surgical also expected the new features to improve operating room efficiency. The company said the medical team can reduce the physical burden from repetitive endoscope manipulation and suction processes and focus on surgery at an ergonomically designed master console.
The new features can be applied through a software update without separate hardware replacement. Hospitals that have already adopted Zamenix can use the new features through a free update.
Chief Executive Kwon Dong-su of Roen Surgical said, "Through continuous updates, including the addition of suction device linkage and automation features, Zamenix will evolve into a platform that enhances hospitals' surgical efficiency and cost-effectiveness," and added, "We will provide a new surgical environment to domestic and overseas adopter hospitals through advanced features that reduce medical staff's surgical fatigue and improve patient safety."
Meanwhile, Zamenix obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) last month. As the world's first AI-based kidney stone surgery robot, it features AI control functions such as respiratory compensation that calibrates robot movement to the patient's breathing, a stone size guide, and autonomous driving.
Zamenix was designated the 17th innovative medical device in 2021 and verified for safety and efficacy through a multicenter clinical trial of 232 cases. It is currently in use at 20 hospitals, including major tertiary general hospitals in Korea, and at one overseas institution.