Domestic surgical robot corporations Roen Surgical said on the 11th that the Zamenix™ P, a kidney stone surgery robot for flexible ureterorenoscopy, obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for medical devices.
The company said it is the world's first FDA clearance for an AI-based flexible ureterorenoscope kidney stone surgery robot.
Zamenix is classified as a Class II medical device by the FDA and has secured eligibility to sell and supply it in the U.S. market.
Zamenix is a robot specialized for retrograde intrarenal surgery (RIRS) using a flexible ureterorenoscope. It can use the same endoscopes and laser equipment that medical institutions have used, and the company said medical staff can remotely manipulate the endoscope to reduce fatigue from long surgeries.
In this clearance review, Zamenix was verified for the reliability of its robot control software and the safety of patient-contact accessories, as well as sterilization and shelf life, biocompatibility, cybersecurity, electrical and mechanical safety, design and usability, and preclinical testing.
In particular, the safety and effectiveness of its proprietary AI features—such as "respiratory compensation," which adjusts endoscope movement to a patient's breathing; a "stone size guide," which helps assess the passability of calculi; and "auto navigation," which automates repeated laser approaches—were demonstrated with objective data.
Roen Surgical plans to use this FDA clearance as a springboard to target the global market, including the United States. It plans to leverage the regulatory verification framework secured during the FDA process for approvals in Europe (CE), Japan, the Middle East, and Southeast Asia.
Kwon Dong-su, CEO of Roen Surgical, said, "Starting with entry into the U.S. market, we will prove Zamenix's competitiveness in the global kidney stone treatment market and promote the excellence of K-surgical robots."
Zamenix was designated as the 17th innovative medical device in 2021 and verified for safety and effectiveness through a multi-center clinical trial involving 232 people. On May 5, it received approval from the National Evidence based Healthcare Collaborating Agency (NECA) for clinical care use of the innovative medical technology. It is currently in use at 20 hospitals in Korea and one institution overseas.