China has given approval for a brain implant designed to aid hand mobility restoration in individuals with severe paralysis. This brain-computer interface (BCI) marks the first of its kind to be authorized for widespread use outside of clinical trials globally.
The apparatus, engineered by Neuracle Medical Technology based in Shanghai, China, secured clearance from the National Medical Products Administration just last week. It will become accessible to patients aged 18 to 60 suffering from quadriplegia resulting from cervical spinal cord injuries.
BCI technology holds significant importance because viable treatment solutions for those with spinal cord injuries remain elusive, states Chen Liang, a neurosurgeon at Huashan Hospital affiliated with Fudan University in Shanghai, who participated in testing the device, named NEO, during its clinical phases.
The development team behind the apparatus compiled 18 months of data, which confirms the operational effectiveness of the BCI system.
Numerous brain-computer interfaces are currently undergoing lengthy evaluations. Last year, Austin, Texas-based neurotechnology firm Paradromics received permission to test a speech-restoring BCI on two participants who had lost the ability to speak due to neurological conditions and trauma.
Neuralink, the brain implant specialty company from Fremont, California, founded by entrepreneur Elon Musk, announced in January that 21 individuals have enrolled in trials for their devices, with testing commencing this year (2024).
Minimally Invasive Approach
The coin-sized NEO device is implanted into the skull; one side features eight electrodes that capture electrical activity generated when a person visualizes moving their opposing hand. These signals are transmitted to a computer, where they are decoded and used to control a glove, enabling users to grasp objects and execute daily tasks like eating and drinking.
Researchers previously documented that one user, utilizing the device for nine months, regained the ability to eat and drink with their right hand—an action impossible before receiving the BCI. This participant exhibited improved capabilities in gripping, pinching, releasing, and general motion in the right hand, and to a lesser degree, in the left hand, which was not assisted by the glove. This individual was part of the clinical trials assessing the implant’s safety and efficacy over a six-month period post-surgery.
Currently, 32 individuals have been fitted with the device, and consistently, all have managed to perform grasping actions via the soft robotic glove, something previously beyond their reach.
NEO distinguishes itself from other devices in current testing—while less invasive than implants placed directly into brain tissue. However, the research cohort remains rather limited for now.
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