Roen Surgical, a surgical robot platform company, announced on July 1 that robot-assisted flexible ureteroscopic lithotripsy using its AI-based kidney stone surgical robot "Zamenix" has become the first in Korea to complete an invasive innovative medical technology clinical trial.
Designated as the No. 17 innovative medical device in 2021, Zamenix is the world's first AI-based kidney stone surgical robot. It removes kidney stones by inserting a 3mm-diameter flexible endoscopic robot through the ureter without incision. The system enhances laser accuracy by tracking moving stones in real time through a respiration compensation function, shortens surgical time through a path replay function, and minimizes damage to the ureter and kidney interior by determining the optimal fragmentation and removal method through a stone size measurement function. By adopting a remote-control approach, the system reduces radiation exposure and physical fatigue for medical staff while improving procedural focus. To date, Zamenix has been introduced at 14 hospitals in Korea and one overseas institution.
The trial directly compared the safety and efficacy of Zamenix against conventional flexible retrograde intrarenal surgery (RIRS), the current standard procedure, through a randomized controlled trial (RCT). The results showed that Zamenix achieved clinical outcomes equivalent to conventional RIRS while demonstrating strengths in manipulation precision and surgical reproducibility. Notably, high stone removal rates were observed even among medical staff with relatively less surgical experience, demonstrating the potential of the robotic platform to narrow proficiency gaps between operators.
This achievement marks the first case in Korea where a domestically developed surgical robot has progressed to institutional framework entry backed by high-quality clinical data. Unlike conventional RIRS, which faced limitations due to high surgical difficulty and dependence on operator proficiency, Zamenix has been recognized for broadening treatment options by integrating robotic technology to enhance surgical convenience and safety.
With the completion of the clinical trial, Zamenix transitions from the research stage to real-world clinical settings. Hospitals can now consider adopting the system regardless of whether they participated in the innovative medical technology trial, and patients can access robot-assisted treatment through regular clinical care rather than as research subjects.
Roen Surgical plans to expand deployment centered on major tertiary hospitals in Korea while leveraging accumulated clinical data to advance AI capabilities and develop next-generation platforms. The company will also use this data as key evidence in global regulatory processes, including the U.S. Food and Drug Administration (FDA) and European CE marking, to pursue entry into overseas markets.
"This trial completion is the first case in Korea where a domestically developed surgical robot has achieved institutional framework entry based on high-quality comparative clinical data," said Kwon Dong-su, CEO of Roen Surgical. "We will actively utilize the large-scale clinical data we have secured to advance AI-based assistive functions and design next-generation platforms, establishing Zamenix as a new global standard for kidney stone treatment."
