China grants world's first market approval for invasive BCI product

SHANGHAI, March 13 (Xinhua) -- China's National Medical Products Administration (NMPA) has recently approved the registration application for an Implantable Brain Computer Interface (BCI) for Hand Motor Augmentation, developed by Neuracle Technology (Shanghai) Co., Ltd., marking the world's first market launch of an invasive BCI medical device.

The newly approved product is also the first invasive BCI medical device to enter the clinical application stage, the developer said on Friday.

Dubbed "NEO," the equipment is intended for patients aged 18 to 60 who suffer from quadriplegia caused by cervical spinal cord injuries and are unable to perform grasping movements with their fingers.

By implanting a coin-sized invasive device, it can collect and decode patients' brain signals in real time, enabling them to control a pneumatic glove through brain signals to perform actions such as grasping objects, picking up items and drinking water.

The product adopts an epidural implantation approach to ensure a high signal-to-noise ratio in brain signal acquisition while avoiding direct damage to brain tissue. Its wireless power supply and communication design allow for a single implantation with long-term use, and patients are able to operate the system independently at home about one month after surgery.

So far, the device has been used in 36 clinical procedures, including four feasibility trials and 32 multi-center Good Clinical Practice (GCP) clinical trials, with all participating patients experiencing varying degrees of improvement in grasping function and some exhibiting signs of neural remodeling and regaining certain neural functions.

The BCI sector, which has been designated a future industry in this year's government work report, is a priority for Shanghai.

The municipality has fostered 60 innovative enterprises dedicated to BCI research and development, with three of their invasive products entering the NMPA's special review procedure for innovative medical devices, and one designated as a Breakthrough Therapy by the U.S. Food and Drug Administration, said the Science and Technology Commission of Shanghai Municipality. ■