First Approval for Invasive Surgical Robot in Korea for Clinical Practice...Non-Reimbursed Prescriptions Now Possible

Roen Surgical's 'Zamenix' Approved for Clinical Use as Innovative Medical Technology
Proven Safety and Efficacy... Now an Official Hospital Treatment Option

Roen Surgical announced on the 18th that its AI-based kidney stone surgery robot 'Zamenix' has received final approval from the National Evidence-based Healthcare Collaborating Agency (NECA) for 'clinical use for the purpose of innovative medical technology'.

AI-Based Kidney Stone Surgery Robot 'Jamenix'. Roen Surgical

Previously, the transition of innovative medical technology to clinical practice in Korea had mainly focused on AI diagnostic software. Zamenix is the first invasive surgical robot in the country to reach this stage, marking a milestone for devices applied directly to patients' bodies.

With this approval, hospitals can now officially operate 'robot-assisted flexible ureteroscopic stone removal (RIRS)' using Zamenix as a clinical treatment item. This enables immediate adoption and revenue generation through non-reimbursed prescriptions.

This approval for clinical use was supported by the first large-scale, multicenter, prospective randomized controlled trial of a surgical robot in Korea, involving 232 patients. In a previous confirmatory study with 46 patients, Roen Surgical recorded a 93.5% stone removal rate, and the large-scale trial further validated Zamenix's efficacy and safety in real-world clinical settings.

Zamenix tracks moving stones in real time using a flexible endoscope with a 2.8mm diameter and an AI-powered respiratory compensation algorithm. This allows for consistent surgical outcomes regardless of the surgeon's proficiency, and by precisely controlling both the endoscope and surgical instruments on a single platform, it significantly reduces medical staff fatigue during complex procedures. Zamenix is currently installed in 16 medical institutions, including Seoul National University Hospital, Severance Hospital, and Samsung Medical Center in Korea and abroad.

The company stated that, starting with this clinical use approval, it plans to fully implement a 'recurring' revenue model in which not only equipment supply but also consumable sales per surgery are generated.

Dongsoo Kwon, CEO of Roen Surgical, said, "This transition for clinical use is meaningful in that it sets a milestone for domestically developed invasive surgical robots to enter the institutional healthcare system based on real clinical evidence. Based on clinical data, we aim to provide safer and more precise surgical benefits to patients not only in Korea but around the world."

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