Roen Surgical’s Zamenix Robot Receives FDA Clearance for AI-Based Kidney Stone Surgery

Roen Surgical, a South Korean surgical robotics company, announced that its Zamenix flexible ureteroscopic kidney stone surgery robot has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

The FDA clearance allows Roen Surgical to market the Class II medical device in the United States, supporting the company's expansion into the global kidney stone treatment market.

Zamenix is designed for retrograde intrarenal surgery (RIRS), a minimally invasive procedure where a flexible ureteroscope is inserted through the urinary tract to locate and treat kidney stones.

The AI-based surgical robot includes functions such as respiratory compensation that synchronizes ureteroscope movement with patient breathing, a stone size guide to help assess urinary tract passage, and autonomous navigation for repeated laser positioning during procedures.

The FDA review evaluated sterilization, shelf life, biocompatibility, software and cybersecurity, electrical and mechanical safety, design verification, usability and preclinical testing. Zamenix can also operate with existing endoscopic and laser equipment, allowing surgeons to remotely control the ureteroscope to help reduce operator fatigue.

Kwon Dong-soo, CEO of Roen Surgical, stated:

"This FDA Class II medical device clearance demonstrates that Zamenix's technology and safety have met some of the world's highest regulatory standards. Starting with our entry into the U.S. market, we will work to demonstrate Zamenix's competitiveness in the global kidney stone treatment market and raise awareness of the capabilities of Korean surgical robotics."

Roen Surgical said Zamenix is the world's first AI-based flexible ureteroscopic surgical robot to receive FDA clearance. The system was designated Korea's 17th innovative medical device in 2021 and its safety and effectiveness were evaluated through a multicenter clinical trial involving 232 patients.

The company plans to pursue regulatory approvals in Europe, Japan, the Middle East and Southeast Asia. Zamenix has been introduced at 20 hospitals in Korea and one overseas institution.