ROEN Surgical, a surgical robot platform company, is set to enter the world’s largest medical device market after receiving the U.S. Food and Drug Administration (FDA) approval for its innovative kidney stone surgery robot.
The company announced on Tuesday that its flexible ureteroscopic kidney stone surgery robot, Zamenix P, has been granted 510(k) clearance by the FDA. This marks a significant milestone as the first AI-based flexible ureteroscopic surgical robot to receive FDA approval.
Zamenix is specifically designed for Retrograde Intrarenal Surgery (RIRS), a procedure that involves inserting a thin endoscope through the urethra to remove kidney stones. This robotic system allows surgeons to operate the endoscope remotely, reducing physical strain and improving surgical precision.
RIRS offers a less invasive alternative to traditional surgery, accessing the kidney through natural passages and using lasers to break down or extract stones. This approach typically results in faster recovery times for patients compared to procedures requiring larger incisions.
In the U.S., Zamenix has been classified as a Class II medical device. During the approval process, the FDA thoroughly evaluated the robot’s control reliability and the safety of patient-contacting components.
ROEN Surgical met rigorous requirements through extensive testing, including sterilization and shelf-life validation, biocompatibility assessments, software and cybersecurity verification, electrical and mechanical safety checks, usability evaluations, and preclinical trials.
The robot incorporates advanced AI features, such as a breathing compensation function that adjusts to the patient’s respiratory movements, a stone size guide to assess stone passability, and an automated laser targeting system.
A key advantage of Zamenix is its compatibility with existing endoscopes and laser equipment used in U.S. hospitals, facilitating easier adoption. Following this FDA approval, ROEN Surgical plans to expand into the U.S. market while pursuing regulatory approvals in Europe, Japan, the Middle East, and Southeast Asia.
In 2021, Zamenix was recognized as Korea’s 17th innovative medical device. It recently received clinical use approval for innovative medical technology from the National Evidence-based Healthcare Collaborating Agency (NECA) after a multicenter clinical trial involving 232 participants. The system is currently in use at 20 hospitals in South Korea and one international facility.
Kwon Dong-soo, Chief Executive Officer (CEO) of ROEN Surgical, stated that this FDA approval validates Zamenix’s technology and safety against global regulatory standards. They’re confident in the ability to demonstrate our competitiveness in the global kidney stone treatment market, starting with the U.S.
