China Approves First Implantable Brain-Computer Interface

China's National Medical Products Administration has approved the world's first implantable brain-computer interface device for commercial use, a milestone aimed at restoring hand function for patients with spinal cord injuries. The device, developed by Shanghai-based Neuracle Medical Technology, received clearance on Friday for adults aged 18 to 60 suffering from quadriplegia caused by cervical spinal cord injuries.

The approval marks a significant step in bringing brain-computer interface technology from experimental stages to clinical application. Neuracle's system, roughly the size of a coin, is implanted minimally invasively on the surface of the brain's outer membrane, avoiding penetration of brain tissue. It uses wireless technology to read neural signals from the motor cortex, which controls movement. These signals are decoded by software to command a robotic glove that assists with grasping and holding objects. The device targets patients who retain some upper arm function but cannot grasp with their hands, with their condition stable for at least six months after standard treatment.

Clinical trials, which began in early 2023, involved 36 successful implant surgeries....