EasyMediBot Begins Product Approval Process for U-BOT Exclusive 'GyneX'

WSI subsidiary EasyMediBot announced on August 3 that its single-use balloon catheter 'GyneX', designed exclusively for U-BOT, will begin product approval procedures at the end of August.

Actual photo of the Ubot-exclusive balloon catheter "Gainex" (top) and a rendering image showing Gainex mounted on the Ubot (bottom) / Photo by WSI

GyneX is a single-use balloon catheter developed for U-BOT. Product development, design, and trademark registration have already been completed. Starting from the end of this month, the company will initiate biological tests, as well as performance and shelf-life tests, to begin the official product approval process for commercialization.

U-BOT is a surgical assistance system that lifts the uterus by inserting a balloon catheter into the patient and controlling it remotely. It has been developed for use alongside existing laparoscopic surgical systems and robot-assisted surgical platforms such as the da Vinci system. It separates adjacent organs such as the uterus, intestines, bladder, and ureter to reduce the risk of damage, and provides a clear incision reference point for safe procedures during hysterectomy and colpotomy.

U-BOT is currently preparing technical documents related to product approval in accordance with international standards for robotic surgical equipment and medical devices both domestically and internationally. The company plans to complete prototype production for usability evaluation by national accredited institutions and for electrical and mechanical safety tests between late August and early September, followed by the related procedures in sequence.

The company is building a recurring revenue business model that supplies both the equipment and single-use balloon catheters. A company representative stated, "We will proceed with the approval process without delay to lay the foundation for commercialization and accelerate our expansion into domestic and overseas markets."

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