From September 7 to 10, 2026, EasyMed Aura (Shenzhen) Medical Co., Ltd., in collaboration with the GUANG DONG MEDICAL DEVICES QUALITY SURVEILLANCE AND TEST INSTITUTE and The Seventh Affiliated Hospital of Southern Medical University, successfully completed usability testing of the Lunara® Neuro Guidewire in Foshan.

Conducted in strict compliance with the EU Medical Device Regulation (MDR) and the IEC 62366-1 usability engineering standard, the testing marks key progress for the company in human factors engineering for neurointerventional devices and in EU regulatory compliance.

Multi-Party Synergy: High-Level Kickoff Meeting Sets Out Testing Standards

On September 7, the kickoff meeting for the neuro guidewire usability testing project was held at the Seventh Affiliated Hospital of Southern Medical University.

The meeting was attended by Liu Guoguang, Party Secretary and Director of the Guangdong Institute, and Wu Jingbiao, Deputy Director; Yu Keqiang, Party Secretary of the Seventh Affiliated Hospital of Southern Medical University and Director of the hospital’s National Drug Clinical Trial Institution; and Zhang Qun, President of the hospital. EasyMed’s Deputy General Manager, together with representatives from the company’s regulatory affairs, registration and R&D teams also attended.

The meeting was co-chaired by Deputy Director Wu Jingbiao and President Zhang Qun. Director Liu Guoguang and Party Secretary Yu Keqiang delivered remarks, stressing that the testing must meet both sets of requirements — human factors engineering and clinical safety

At the meeting, Shen Wenrou, Registration Specialist at EasyMed, gave a product presentation, and Xu Yuchun, Head of the Public Testing Platform for Active Medical Devices at the Guangdong Institute, explained the testing protocol and execution details. All parties held in-depth discussions on test task design, evaluation metrics and risk control.

Anchored in Clinical Scenarios: Key Operational Tasks Systematically Validated

Throughout the testing, the parties collaborated closely. Neurointerventional specialists from the Seventh Affiliated Hospital of Southern Medical University served as target users and completed the operational evaluations; the Guangdong Institute provided expert guidance throughout; and EasyMed’s R&D, registration, quality and clinical teams provided end-to-end support.

Closely aligned with the real-world clinical use scenarios of the Lunara® Neuro Guidewire, the testing recreated catheterization laboratory conditions and focused on key tasks including guidewire pushability, torque transmission precision, tip shaping adaptability and microcatheter exchange compatibility, systematically capturing operational performance,operators’ subjective feedback and potential use-related risk points.

Multiple rounds of simulated procedures validated the product’s usability and safety in its intended use environment, providing human factors evidence to support subsequent design optimization, risk management iteration and the EU MDR submission.

Deepening Collaborative Innovation: Steadily Advancing Compliance and Clinical Translation

The successful completion of this usability testing is a highly effective demonstration in practice of the “industry–academia–research–clinical–testing” collaborative innovation mechanism. EasyMed extends its gratitude to the expert teams of the Guangdong Institute and the Seventh Affiliated Hospital of Southern Medical University for their technical guidance, and to all company departments for their dedicated efforts throughout the testing.

Going forward, the project team will systematically consolidate the testing data, produce a formal usability test report, and advance design closure and registration submission.

EasyMed will continue to uphold compliance-first and clinically oriented principles, steadily advancing EU market access and clinical translation of the Lunara® Neuro Guidewire, and providing safer, more user-friendly minimally invasive interventional treatment solutions for the neurointerventional field.