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Source: People's Republic of China in Russian – People's Republic of China in Russian –
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Source: People's Republic of China – State Council News
SHANGHAI, March 14 (Xinhua) — China's National Medical Products Administration (NMPA) on Monday approved the marketing application for an implantable brain-computer interface (BCI) for improving hand motor skills developed by Neuracle Technology (Shanghai) Co., Ltd., marking the world's first commercialization of an invasive medical BCI device.
The newly approved product is also the first invasive medical device to enter clinical use, the developer announced Friday.
This medical product, called “NEO”, is intended for use by patients aged 18 to 60 years who suffer from quadriplegia caused by cervical spinal cord injury and have lost the ability to perform grasping movements with their fingers.
Implanting an invasive, coin-sized device that can collect and decode brain signals in real time allows the patient to control a pneumatic glove with their thoughts and perform actions such as grasping, lifting objects, and drinking.
This device is implanted epidurally, ensuring high signal quality while reducing the risk of brain tissue damage. Thanks to its wireless power supply and communication system, the device can be implanted once and used for a long time, and patients can independently control the system at home approximately one month after surgery.
To date, the device has been used in 36 clinical trials, including four pilot studies and 32 multicenter clinical trials conducted in accordance with good clinical practice standards. All participants experienced some improvement in grip function, and some showed signs of restoration of neural connections and partial return of nerve function.
The IMC sector, which was named the industry of the future in this year's government work report, is a priority for the development of the metropolis of Shanghai (East China).
The Shanghai Science and Technology Commission reported that the municipality has supported 60 innovative enterprises engaged in the research and development of IMCs, with three of their invasive products having passed the NMPA's special inspection procedure for innovative medical devices, and another similar product having been designated as a "breakthrough therapy" by the US Food and Drug Administration (FDA). -0-
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