(Yicai) March 13 -- Chinese medical device firm Neuracle Technology has won regulatory approval for its brain-computer interface product, which is designed to restore hand motor function, making it the first such system in the world to reach the clinical application stage.

The implantable brain-computer interface product, which helps restore hand grasping ability through a pneumatic glove, has been cleared under the innovative product registration pathway by the National Medical Products Administration. It is designed for patients aged 18 to 60 who suffer from quadriplegia caused by cervical spinal cord injuries.

The system uses minimally invasive implantation through the dura mater, the brain’s outermost membrane, and features wireless power supply and communication technology. Clinical trial results showed that subjects achieved a significant improvement in hand-grasping ability, which improved their quality of life, the regulator said.

The brain-computer interface device entered clinical trials in 2023 and to date and has completed 36 implant surgeries, the Shanghai-based firm, whose core team hails from the neuro-engineering laboratory of Tsinghua University, told Yicai. All patients successfully achieved brain-controlled grasp assistance and rehabilitation training.

In China, brain-computer interface technology has been designated by authorities as one of the key industries of the future. After years of strategic planning, Shanghai has formed a relatively complete brain-computer interface industrial chain and aims to become a global innovation hub for the sector.

Shanghai plans to accelerate the clinical adoption of the product and establish standardized treatment and rehabilitation procedures, an official from the Shanghai Municipal Science and Technology Commission told Yicai. It aims to achieve the first clinical use of the device this year while continuing to improve manufacturing processes to enable large-scale production and to reduce costs.

Because brain-computer interface technology is a multidisciplinary field involving chips, polymer materials, precision manufacturing and life sciences, it places high demands on the industrial supply chain, said Xu Hong, who founded Neuralce in 2011.

Shanghai has gathered a large number of biopharmaceutical and semiconductor companies, as well as authoritative medical device testing institutions, which has greatly bolstered Neuralce’s R&D efficiency, he added.

The megacity has already nurtured nearly 60 brain-computer interface companies, including Neuralce, NeuroXess and StairMed Technology, and plans to achieve full clinical adoption of brain-computer interface products by 2030, according to the local government.

Editors: Dou Shicong‌, Kim Taylor