Neuracle Technology has received marketing approval from China’s National Medical Products Administration (NMPA) for its invasive brain-computer interface (BCI) device.
The approval applies to an implant designed for adult patients who are partially paralysed as a result of spinal cord injury.
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According to clinical trials, the BCI product has assisted patients in regaining the ability to grab and hold objects with their hands.
The device is said to be among several technologies in development by Chinese companies seeking to enable control of electronic devices using only thought.
The government aims to foster globally competitive companies in this area by streamlining regulatory review processes and creating reimbursement guidelines before product launch.
The announcement of the approval led to increased share prices among companies involved in BCI technology on the Hong Kong stock exchange, including Innovation Medical Management, Nanjing Panda Electronics, and Sanbo Hospital Management Group, each rising more than 10%.
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By GlobalDataNeuracle’s approved system consists of implanted sensors, a brain signal decoding algorithm, a robotic glove, surgical instruments, clinical management software and medical testing software.
The product is authorised only for individuals who retain some upper arm function, limiting its use compared to other implants that have demonstrated broader applications such as allowing fully paralysed patients to browse online or play video games.
This restriction reflects the system’s design. Neuracle’s implant uses fewer signal-detection channels and is positioned outside the outer membrane of the brain, unlike others that employ more channels or deeper placement.
In another BCI investment development, Shanghai StairMed Technology recently closed a 500m yuan ($72.6m) funding round led by Alibaba Group Holding, with plans for further patient trials of a brain chip this year.
