The 1st Domestically Developed Invasive BCI Device Got Approved in China
“Mingtong (明瞳）,” a functional neurosurgical electrophysiological recording and stimulation device, has been officially approved for market release by China’s National Medical Products Administration (NMPA). Developed by Nanjing Science Health Medical Technology Co., Ltd., it is the first domestically developed Class III invasive BCI medical device in China. The device represents a significant technological breakthrough and clinical efficacy according to the manufacturer.
The Mingtong device is primarily used in deep brain stimulation (DBS) surgeries to assist surgeons in the accurate implantation of electrodes with the following features:
- Closed-Loop BCI Functionality: The device supports real-time intraoperative neural signal acquisition and dynamic regulation. This aligns with the NMPA’s definition of BCI technology, which includes signal decoding and feedback.
- Clinical Efficacy: By leveraging high-precision signal acquisition, real-time neuro-navigation, and multi-modal stimulation, the device aims to improve the efficacy and safety of surgeries for neurological disorders such as Parkinson’s disease.
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