Shanghai: 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, according to China Daily.
According to Azerbaijan State News Agency, the National Medical Products Administration stated 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, as confirmed by the company, which was founded in 2011.
This medical device targets patients aged between 18 and 60 suffering from quadriplegia due to cervical spinal cord injuries, which prevent them from grasping objects. Using 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 to perform actions like grasping and drinking, thus bridging 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. This technique ensures a high signal-to-noise ratio while avoiding brain tissue damage. The wireless power and communication design facilitate one-time implantation and long-term use, with surgery taking slightly over an hour. Patients can generally operate the system independently at home one month post-surgery.
In clinical trials with 36 participants, the device showed a 100 percent improvement rate in their grasping function, with some patients exhibiting signs of neural remodeling and recovering additional nerve functions, according to the company.
Compared to similar technologies worldwide, this product offers benefits in trauma control, patient compliance, and long-term stability, addressing the challenges of high trauma and maintenance needs associated with traditional invasive techniques.