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Chinese medical device company Neuracle Technology has received approval from regulators for its groundbreaking brain-computer interface system, designed to restore hand motor function. This marks the first such device worldwide to advance to the clinical application stage.
The implantable system, which aids in restoring hand grasping via a pneumatic glove, was approved through an innovative registration pathway by the national medical regulatory authority. It targets patients aged 18 to 60 who have quadriplegia resulting from cervical spinal cord injuries.
The device is implanted with minimal invasiveness through the dura mater—the outer membrane covering the brain—and incorporates wireless power and communication technology. Clinical trial data demonstrated notable improvements in patients’ hand grasping abilities, significantly enhancing their quality of life.
Since entering clinical trials in early 2023, the Shanghai-based firm has performed 36 successful implant surgeries. The company’s core team, originating from Tsinghua University’s neuro-engineering laboratory, reports that all patients achieved brain-controlled grasp assistance and successful rehabilitation training.
In China, brain-computer interface (BCI) technology has been prioritized as a key future industry. After years of strategic development, Shanghai has built a relatively comprehensive BCI industry ecosystem and aspires to become a global innovation hub in this sector.
Local authorities plan to accelerate the clinical integration of the device and establish standardized protocols for treatment and rehabilitation. The goal is to see the device used in clinics by this year, with ongoing efforts to refine manufacturing processes for large-scale production and cost reduction.
Considering the multidisciplinary nature involving chip design, polymer materials, precision manufacturing, and life sciences, BCI technology demands a robust industrial supply chain. Xu Hong, founder of Neuracle, highlighted that Shanghai’s concentration of biopharmaceutical companies, semiconductor firms, and top medical device testing institutions has greatly boosted research and development efficiency.
The city has cultivated nearly 60 companies in the BCI field, including Neuracle, NeuroXess, and StairMed Technology. The local government aims for full clinical adoption of BCI products across China by 2030.
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