Zamenix, a kidney stone surgery robot developed by medical robotics company Roen Surgical, has received Class II clearance from the U.S. Food and Drug Administration (FDA).
Class II designation applies to medical devices directly linked to patient safety. To gain entry into the U.S. market, devices must undergo rigorous verification covering safety, performance, and comprehensive quality-management systems. With this clearance, Roen Surgical can officially market and supply Zamenix across the United States.
Zamenix performs flexible ureteroscopic stone surgery, a minimally invasive procedure where an endoscope is navigated through the urethra and bladder to reach the kidney without skin incisions. The system then uses a laser to safely break apart and remove kidney stones that are difficult to treat with extracorporeal shock wave lithotripsy. Traditionally, surgeons had to perform these delicate procedures manually, holding the endoscope while standing in a hunched posture for hours.
AI-Assisted Remote Control Elevates Precision and Ergonomics
Roen Surgical addressed these physical and procedural limitations by equipping Zamenix with a real-time monitor, a remote control console, and artificial intelligence features that partially automate the surgery. The robot incorporates several proprietary AI capabilities, including a respiratory compensation function that synchronizes ureteroscope movement with the patient's breathing, a stone size guide to assess whether fragments can pass naturally, and an auto-navigation feature that automates repetitive laser alignment.
Zamenix is the first AI-powered flexible ureteroscopic surgical robot to obtain FDA clearance. Because the global surgical robotics market is heavily centered in North America and Europe, Roen Surgical expects this regulatory milestone to accelerate its international expansion.
“This FDA clearance confirms that Zamenix’s technology and safety meet the world’s most stringent regulatory standards,” said Kwon Dong-soo, CEO of Roen Surgical. “Beginning with our entry into the U.S. market, we will do our utmost to prove Zamenix’s competitiveness globally and highlight the excellence of Korean surgical robotics.”
Roen Surgical plans to leverage the regulatory validation established through this clearance process to pursue subsequent approvals across Europe, Japan, the Middle East, and Southeast Asia.
