An implantable brain-machine interface system for hand movement compensation by Neuracle Technology (Shanghai) Co Ltd received China's medical device registration certificate on Friday, becoming the world's first implantable BMI medical device of its kind to gain market approval.?

The National Medical Products Administration said that the approval marks the entry of the world's first invasive BMI medical device into the clinical application stage. The device is set to achieve its first clinical application on a patient within this year, according to the company founded in 2011.

This medical device is designed for patients aged between 18 and 60 who suffer from quadriplegia due to cervical spinal cord injuries, rendering them unable to grasp objects. Utilizing a coin-sized minimally invasive implant, the system extracts and analyzes brain signals in real-time, enabling patients to control specific gloves with their thoughts so as to perform actions like grasping and drinking, thus filling a gap in the global commercialization of such technologies.

A core innovation of the device is its extradural implantation technique, where electrodes are placed outside the dura mater, ensuring high signal-to-noise ratio while avoiding brain tissue damage. The wireless power and communication design allow for one-time implantation and long-term use, with surgery taking just over an hour. Patients can usually operate the system independently at home one month after the surgery.

In clinical trials involving 36 participants, the device demonstrated a 100 percent improvement rate in their grasping function, with some patients showing signs of neural remodeling and recovering additional nerve functions, according to the company.

Compared with similar technologies abroad, this product offers advantages in trauma control, patient compliance, and long-term stability, addressing the challenges of high trauma and maintenance needs associated with traditional invasive techniques.