[Shanghai, China] – February 2026 — MicroPort® MedBot™ announced that its Toumai® laparoscopic surgical robotic system has received CE marking under the European Union Medical Device Regulation (MDR) for pediatric surgical indications, extending the system's approved use to eligible pediatric patients undergoing minimally invasive surgery within the European Union.

Pediatric surgery presents unique technical challenges compared with adult procedures due to smaller anatomical structures, more delicate tissues, and lower physiological tolerance. These factors place increased demands on imaging quality, instrument dexterity, and overall system performance. Under the EU MDR, pediatric indications require comprehensive clinical evidence demonstrating safety, effectiveness, and performance under intended conditions of use.

To support the pediatric indication, MicroPort® MedBot™ conducted multicenter clinical studies in accordance with international standards. The studies included representative pediatric procedures across urology, oncology, thoracic surgery, mediastinal surgery, and conventional laparoscopic surgery to evaluate the system's safety and effectiveness in pediatric patients.

The CE marking expands the approved clinical application of the Toumai® surgical robotic system in Europe and supports broader adoption of robotic-assisted minimally invasive surgery for eligible pediatric patients. MicroPort® MedBot™ will continue collaborating with clinical partners to advance robotic-assisted surgery across multiple specialties and patient populations.

About MicroPort® MedBot™

Commenced development of laparoscopic surgical robots in 2014 and officially established in Shanghai in 2015, Shanghai MicroPort MedBot (Group) Co., Ltd. ("MicroPort® MedBot™", stock code: 02252.HK), a subsidiary of MicroPort Scientific Corporation ("MicroPort®", stock code: 00853.HK), is currently the only surgical robotics company with businesses spanning five major segments: laparoscopic, orthopedic, vascular interventional, natural orifice, and percutaneous surgical robotics.

MicroPort® MedBot™ integrates robotics, intelligent control, image-guided navigation, and precision imaging technologies to develop intelligent surgical solutions that support minimally invasive care worldwide.

Regulatory Disclaimer

The Toumai® laparoscopic surgical robotic system has received CE marking in the European Union for pediatric surgical indications. Regulatory status varies by country and region. Not all indications or uses described in this release may be approved in all markets. Healthcare professionals should refer to applicable local regulatory requirements and the product instructions for use.

References

Data on file, MicroPort® MedBot™. Supporting clinical documentation for the CE MDR pediatric indication.