Roen Surgical's "Zamenix" Receives FDA Clearance as AI-based Kidney Stone Surgery Robot

Global Technology Validated with Class II Medical Device Clearance

Safety Proven with Features such as Respiratory Compensation, Stone Size Guide, and Automatic Travel Functions

Roen Surgical announced on the 11th that its independently developed flexible ureteroscopic kidney stone surgery robot, Jamenics, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

Jamenics was approved as an FDA Class II medical device. This classification applies to devices directly related to patient safety. It has been validated for the reliability of robot control, safety of patient-contacting accessories, as well as sterilization, shelf life, biocompatibility, software and cybersecurity, electrical and mechanical safety, and preclinical testing.

Roen Surgical emphasized that Jamenics is the world's first AI-based flexible ureteroscopic surgery robot to receive FDA approval, making the milestone particularly significant.

Jamenics is equipped with features such as a "respiratory compensation function" that adjusts the movement of the endoscope in sync with the patient's breathing, a "stone size guide" that assists in determining the possibility of stone passage, and an "automatic driving function" that automates repeated laser access. Another notable advantage is that existing endoscopes and laser equipment can still be used, reducing the burden of equipment replacement for medical institutions, and remote operation helps decrease the operator's procedural fatigue.

With the flexible ureteroscopic kidney stone surgery (RIRS) market still in its early stages, Roen Surgical plans to use this FDA approval as a springboard to gain a competitive edge in the global arena. The company intends to leverage its FDA approval experience to obtain other international certifications, including European CE, and to expand into Japan, the Middle East, and Southeast Asia. It also plans to actively pursue collaborations with global medical device distributors and healthcare providers.

Jamenics was designated as the 17th innovative medical device in 2021 and has demonstrated safety and effectiveness in a multi-center clinical trial involving 232 patients. In May this year, it received approval for clinical use as an innovative medical technology from the National Evidence-based Healthcare Collaborating Agency (NECA) in Korea. It is currently in use at 20 hospitals in Korea and one institution overseas.

Dongsoo Kwon, CEO of Roen Surgical, stated, "FDA Class II clearance signifies that the technology and safety of Jamenics have met the world's highest regulatory standards. Starting with the U.S. market, we aim to prove our competitiveness in the global kidney stone treatment sector."

AI-Based Kidney Stone Surgery Robot Jamenics. Roen Surgical

This content was produced with the assistance of AI translation services.