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China’s National Medical Products Administration has approved Borui Kang Medical Technology’s (Neuracle) brain-computer interface system for commercial sale in patients aged 18 to 60 with quadriplegia resulting from cervical spinal cord injury. Reuters described the decision as the world’s first approval of a BCI device for commercial use outside clinical trials.
The product, called NEO, is intended to help eligible patients recover hand-grasping function through a glove directed by decoded neural signals. The system uses minimally invasive extradural implantation and wireless technology. The coin-sized device is embedded in the skull, where eight electrodes capture brain activity linked to intended movement of one hand and send those signals to a computer that controls the glove.
The approval opens a commercial pathway for a patient group with limited treatment options. Regulator-reviewed clinical data showed meaningful improvement in hand-grasping ability and associated quality-of-life benefit. Nature reported that the team has collected up to 18 months of follow-up data, which collaborator Zhengwu Liu said is unusual in the field. Chen Liang, a neurosurgeon involved in the trial, said 32 patients have received the implant and all were able to perform a grasping movement using a soft robotic glove. Chen said the team is preparing the trial results for publication.
Sources: Reuters, Nature
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