A South Korean robotics maker has secured U.S. regulatory approval for an AI-assisted kidney stone surgery robot it bills as a world first. The FDA’s 510(k) ruling lets Roen Surgical sell the Class II system on the U.S. market.
Zamenix is built for retrograde intrarenal surgery, a minimally invasive procedure in which a flexible ureteroscope travels through the urinary tract to find and treat stones.
Three AI functions stand out: breathing-synchronized scope movement, a guide that estimates whether a stone can pass through the urinary tract, and automated laser positioning during the case.
Surgeons can steer the ureteroscope from a remote console instead of holding it for long periods, a design Roen says cuts operator fatigue, and the robot works alongside existing endoscopes and lasers. Software, cybersecurity and sterilization were all part of the FDA review. Biocompatibility, mechanical and electrical safety, usability and preclinical testing rounded out the assessment.
Roen also points to a 232-patient clinical study that assessed the system. Europe, Japan, the Middle East and Southeast Asia are next on Roen’s regulatory agenda, the company said. Kwon Dong-soo, the CEO, framed the clearance as proof that Zamenix meets some of the world’s strictest standards.
