NCC Electrophysiology’s High-Channel IONM System Received China’s First Category III Registration for Orthopedic and Neurosurgical Use

A regulatory milestone for high-channel intraoperative neurophysiological monitoring

On July 2, 2024, our intraoperative nerve stimulation monitoring system, registered under National Medical Products Administration registration number 20243071197, received China’s first Category III medical-device registration for a high-channel intraoperative neuromonitoring system designed for orthopedic and neurosurgical procedures.

The system was developed entirely with independent intellectual property rights and represented another milestone in the development of domestic electrophysiology equipment.

High-Channel Monitoring for Intraoperative Neurophysiology

The system featured:

• 32-channel intraoperative EMG and evoked-potential monitoring; and
• 256-channel intraoperative EEG and evoked-potential monitoring.

The system supported neurophysiological monitoring and protection in orthopedic, neurosurgical, head and neck surgery and other surgical settings. Its high-channel configuration expanded the range of neurophysiological signals available for intraoperative monitoring.

The product also received support from the Shanghai Municipal Commission of Economy and Informatization’s 2022–2023 High-Quality Development Special Project for Biomedicine, under the project titled “Industrialization and Application of High-End Intraoperative Nerve Stimulation Monitoring Equipment”.

Building a Category III IONM Portfolio

Our development in Category III intraoperative neuromonitoring began with a series of regulatory milestones:

• Neural monitoring endotracheal tube — National Medical Products Administration registration number 20213070476; Category III registration approved on June 24, 2021;
• Intraoperative nerve stimulation monitoring system — National Medical Products Administration registration number 20213070856; Category III registration for an intraoperative neuromonitoring system approved on October 26, 2021;
• Disposable needle electrode — National Medical Products Administration registration number 20233070451; Category III registration approved on April 6, 2023; and
• High-channel intraoperative nerve stimulation monitoring system — National Medical Products Administration registration number 20243071197; Category III registration for orthopedic and neurosurgical use approved on July 2, 2024.

Together, these milestones reflected our continued work to develop an integrated intraoperative neuromonitoring portfolio covering monitoring equipment, specialized airway products and disposable electrodes.

Continuing to Develop Intraoperative Monitoring Solutions

The Category III registration of our 32+256-channel intraoperative nerve stimulation monitoring system marked an important step in the development of domestic high-channel IONM equipment.

We continued to focus on technical innovation, regulatory development and clinical collaboration. Through ongoing research and cooperation with clinical partners, we continued to advance intraoperative neurophysiological monitoring solutions for relevant surgical settings.