ROEN Surgical
2 known investors
Robotic endoscope platform development
Also known as Roen Surgical Inc. Β· μ£Όμνμ¬ λ‘μμμ§μ»¬
Investors Β· 2
Company profile
researched Aug 2026ROEN Surgical (Roen Surgical Inc.) is a medical device company based in Daejeon, South Korea, that develops a next-generation surgical robot platform based on flexible robot technology for minimally invasive surgery. The company was founded in 2018, drawing on robotics research conducted at KAIST, and is led by CEO Kwon Dong-soo, a former KAIST mechanical engineering professor.
Its principal product, Zamenix, is an AI-based flexible ureteroscopic surgical robot for kidney stone treatment. The system pairs a 2.8-millimeter flexible endoscopic robot with a master console; the robot passes through the urethra and ureter without incisions while the surgeon operates from the console. AI functions assess in real time whether a stone is small enough to pass through the ureter and support laser fragmentation of larger stones. The company states the system reduces operator fatigue relative to manual endoscope operation over long procedures and can be used with existing endoscopic and laser equipment without replacement. The company is classified under medical equipment manufacturing and reported a headcount in the 21-50 range.
Founding story
Roen Surgical was established in 2018 on the basis of KAIST's robotics research and more than 25 years of associated research work, by Kwon Dong-soo, previously a professor of mechanical engineering at KAIST, who serves as CEO.
Traction
Zamenix was evaluated in a multicenter clinical trial of 232 patients in South Korea and received approval in May 2026 from the National Evidence-based Healthcare Collaborating Agency (NECA) for clinical use as an innovative medical technology. It has been adopted at more than 20 hospitals and received FDA 510(k) clearance as a Class II device in August 2026.
Latest developments
In August 2026 the company announced that Zamenix had received 510(k) clearance from the U.S. Food and Drug Administration as a Class II device, and stated it would use the regulatory validation system built during the FDA process to pursue clearances in Europe, Japan, the Middle East and Southeast Asia ahead of U.S. market entry.
βΈFull profile β market position, technology, go-to-market, geography
Market position
The company describes Zamenix as the first AI-based flexible ureteroscopic surgical robot to receive FDA clearance, positioning it in the global kidney stone treatment segment of the surgical robotics market.
Technology
The company builds flexible (continuum) robotic systems for minimally invasive surgery. Zamenix consists of a 2.8-mm flexible endoscopic robot and a master console from which the surgeon drives the device transurethrally. Embedded AI functions evaluate in real time whether a stone can pass through the ureter and guide laser fragmentation of larger stones for removal. The system is designed to work with existing endoscopic and laser equipment. In FDA review the device met requirements for sterilization and shelf-life verification, biocompatibility, software and cybersecurity validation, electrical and mechanical safety, design verification, usability assessment and preclinical testing.
Go-to-market
Hospitals and urological surgeons performing kidney stone removal procedures; the system had been adopted at more than 20 hospitals as of August 2026.
Geography
Headquartered in Daejeon, South Korea. The device is in clinical use in South Korea and the company has obtained U.S. FDA clearance; it plans to pursue approvals in Europe (CE), Japan, the Middle East and Southeast Asia.
Compiled by commissioned research from 3 cited public sources β announcements, filings, and press listed under research sources below.
Key figures
latest reportedCompany-reported or press-reported figures, each dated to when it was claimed β not independently audited.
Timeline Β· 2
launches, deals, and filingsRoen Surgical announced that Zamenix, its AI-based flexible ureteroscopic surgical robot for kidney stones, received 510(k) clearance from the U.S. FDA, recognized as a Class II device. The review focused on control reliability and safety of patient-contacting components.
Following a multicenter clinical trial of 232 patients, the National Evidence-based Healthcare Collaborating Agency approved Zamenix for clinical use as an innovative medical technology in South Korea.
Dated company events from announcements, filings, and press; legal rows summarize public dockets and regulator releases.
βΈResearch sources Β· 3
primary sources listed
- ROEN Surgical Overview, Address & Contactprospeo.io Β· web
3 public sources were cited for this profile; the first-party ones are listed here.
Frequently asked questions
- What does ROEN Surgical do?
- Korean surgical robot company developing Zamenix, an AI-based flexible ureteroscopic robot for kidney stone removal.
- Who are ROEN Surgical's investors?
- ROEN Surgical's investors include Kiwoom Investment, KT investment Inc..