WSI subsidiary EZMedibot completes U-BOT prototype, begins product-approval testing

[Financial News] WSI subsidiary EZMedibot has completed a prototype for regulatory review of U-BOT, a uterine-elevation robot for gynecological surgery, and has begun testing and evaluation for regulatory approval.
EZMedibot said on the 3rd that it had completed production of a prototype for regulatory review of U-BOT and was conducting safety testing required for product approval from the Ministry of Food and Drug Safety.
The prototype is a physical version of U-BOT, which had previously been unveiled through rendered images. The company will conduct electrical and mechanical safety tests and a usability evaluation using the completed prototype.
To that end, it filed a request for electrical and mechanical safety testing with the Korea Testing & Research Institute (KTR) on September 23. It plans to deliver two prototypes by the 6th, while usability evaluations will also be carried out at the Medical Device Research and Development Center at Seoul National University Bundang Hospital.
Four international standards are set to apply to the testing and evaluation: IEC 60601-1 for electrical and mechanical safety, IEC 60601-1-2 for electromagnetic safety, IEC 60601-1-6 for usability, and IEC 80601-2-77 for the safety of surgical robots.
U-BOT is a robot developed to automate uterine elevation—the adjustment of the uterus’s position and angle—during gynecological laparoscopic surgery. It is designed to let the surgeon directly control the position of the uterus, and the company has secured related core patents in Korea, the United States and Europe.
Based on the test results, EZMedibot plans to pursue product approval from the Ministry of Food and Drug Safety (MFDS) in Korea and the issuance of an international certificate under the International Electrotechnical Commission System for Conformity Testing and Certification of Electrical Equipment (IECEE). The testing and evaluation data will also be used to prepare for regulatory approval from the U.S. Food and Drug Administration (FDA) and CE marking under European medical device regulations.
An industry source in the medical device sector said, “Completing a prototype for regulatory review means moving from the design stage to validation using physical equipment. The data gathered in future safety and usability evaluations will be a key foundation for preparing for regulatory approval.”
A company representative said, “With production of the prototype for regulatory review now complete, we can conduct the tests and evaluations required for product approval using the actual U-BOT unit. We will carry out safety and usability validation and prepare for regulatory approvals in Korea and overseas.”
[email protected] Choi Doo-seon Reporter