The world's first market launch of an invasive BCI (brain-computer interface) medical device has become a reality, after China's National Medical Products Administration  recently approved the registration application for an implantable BCI device to restore hand motor function. Developed by Shanghai-based Neuracle Technology, it also signifies a shift from experimental to clinical use.

The product is designed to help patients aged 18 to 60 who suffer from quadriplegia caused by cervical spinal cord injuries and are unable to perform grasping movements.

Two electrodes are implanted without direct contact with brain tissue to ensure implantation safety and signal effectiveness. When connected to an external device such as a pneumatic glove and activated, the coin-sized invasive device can collect and decode the patients' electroencephalogram (EEG) signals in real time, allowing for control of the pneumatic glove through thoughts to perform actions including grasping and picking up objects, and drinking water.

There is also no need for frequent battery replacements for patients as the device is powered wirelessly via a magnetic coil.

Patients are able to operate the device independently at home about one month after surgery.

The device has been used in clinical trials since 2023, with a total of 36 patients enrolled. Data showed that all participants experienced varying degrees of improvement in grasping function, while some patients have exhibited signs of neuroplasticity with additional partial recovery of neurological function.