World's First! China's Intracranial Brain-Computer Interface Medical Device Approved for Market Launch, Marking a New Era of Clinical Application

Recently, the global brain-computer interface field has made a milestone breakthrough. The National Medical Products Administration has officially approved the innovative product registration application of the "Implantable Brain-Computer Interface Hand Motor Function Compensation System" developed by BioSensory Technology (Shanghai) Co., Ltd.. This not only marks the global first launch of this type of medical device, but also signifies that the world's first invasive brain-computer interface medical device has officially entered the clinical application stage.

Core Technologies and System Components

The system uses minimally invasive epidural implantation and wireless power supply and communication technologies, balancing signal quality and surgical safety. The complete product consists of eight core components:

• Hardware: Brain-computer interface implant, implanted EEG electrode kit, EEG signal transmitter and receiver, pneumatic glove device.

• Software and Accessories: EEG decoding software, medical testing software, clinical management software, and a dedicated single-use surgical tool kit.

Target Population and Clinical Performance

This product is precisely targeted at patients with quadriplegia caused by cervical spinal cord injury. By capturing the brain's motor intentions and driving the pneumatic gloves, it helps patients compensate for hand grasping function. Patients applying for this treatment must meet the following strict criteria:

1. Age and Medical History: 18 to 60 years old, diagnosed for more than one year, and stable for at least six months.

2. Injury Level: C2-C6 cervical spinal cord injury, classified as grade A to C quadriplegia.

3. Physical Indicators: Complete inability to grasp with the hands, but the upper arm still has partial function.