Surgeons at Huashan Hospital, affiliated with Fudan University in Shanghai, implanted a Chinese-made brain-computer interface into a paralyzed patient on July 13, in what hospital officials and Chinese state media described as the world’s first commercial procedure using a device with full regulatory market approval.
The patient, who lost hand mobility after a spinal-cord injury in a car accident a decade earlier, received the NEO system, built by Shanghai-based Neuracle Technology. Unlike deep-penetrating implants such as Neuralink’s, NEO sits on the surface of the brain’s sensorimotor cortex rather than piercing tissue, using eight coin-sized electrodes to record neural signals and translate a patient’s intent to move into actual hand motion. According to Global Times, hospital staff said the epidural signals recorded during surgery were stable and of good quality, and the patient’s vital signs remained normal afterward.
A regulatory first
China’s National Medical Products Administration granted NEO a Class III device registration on March 13, which the company and domestic outlets describe as the first market approval anywhere for an implantable BCI product. Within four months, Neuracle completed manufacturing, hospital rollout and patient screening; the device’s price was filed with China’s medical insurance system on April 28, and the July 13 surgery is now covered under Shanghai’s “Hui Bao” supplementary commercial health plan for eligible patients.
Huashan Hospital president Mao Ying said BCI devices “may expand from high-cervical spinal cord injury to more scenarios,” while professor Lü Baoliang called the operation a “major step toward the technology’s transition from clinical trials to routine medical care.”
Backed by trial data
The approval rested on a 32-patient trial in which, three months after implantation, every participant showed a measurable grasp response on the Action Research Arm Test, a standard clinical measure of hand function, and just over two-thirds gained at least six points on the test compared with their pre-surgery baseline. Investigators reported no device-related adverse events.
The milestone lands the same week China hosted Xi Jinping’s keynote at Shanghai’s World AI Conference, part of a broader government push into frontier technology, including AI’s growing role in healthcare. For more on how these devices work, see our explainer on brain-computer interfaces.