HONG KONG, March 13 (Reuters) – China’s drug regulator said on Friday that it has given the nod for a brain-computer interface (BCI) system that helps restore hand-movement ability to be sold, the world’s first approval of a BCI device for commercial use.
• The device is made by Borui Kang Medical Technology (Shanghai) and its tech aims to restore movement and communication to humans suffering from different forms of paralysis.
• It is designed for patients with quadriplegia caused by cervical spinal cord injuries, helping them regain hand‑grasping ability via a glove.
• The product is an invasive BCI system, which means electrodes are inserted directly into the brain, instead of sitting on the surface of the brain. The device uses minimally invasive extradural implantation, relying on wireless technology.
• The National Medical Products Administration said BCI products like the one approved on Friday have been prioritised, noting the sector has been designated a “future industry” in Beijing’s latest five-year plan released last week.
• China could see brain-computer interface (BCI) technology move into practical public use within three to five years as products mature, a leading BCI expert told Reuters last week, as Beijing races to catch up with U.S. startups including Elon Musk’s Neuralink.
• Eligible patients for the product must be aged 18 to 60 and suffer from a specific kind of spinal cord injury. Their diagnosis must be at least a year old, and they must be in a stable condition for six months following standard treatment. Patients must be unable to grasp with their hands but retain some upper‑arm function.
• Clinical trial data showed significant improvement in hand‑grasping ability among participants, the regulator said, adding that the gains helped enhance patients’ quality of life.
(Reporting by Jessie Pang, Eduardo Baptista, Laurie Chen and the Beijing newsroom; Editing by Edwina Gibbs)
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