China has just approved its first brain implant for commercial use, a world first

China has just approved its first brain implant for commercial use, a world first

By Tanya Lewis edited by Claire Cameron

In a world first, China has approved a brain implant for commercial use in people with spinal cord injuries.

The device is a type of brain-computer interface (BCI) and is made by Shanghai-based Neuracle Medical Technology – a potential rival to Elon Musk’s BCI startup Neuralink. Brain implants have been used as part of clinical trials for decades, but this is the first time such a device has been approved for widespread use in patients.

BCIs, sometimes known as brain-machine interfaces, are devices that record brain activity. Invasive BCIs like Neurakles are surgically implanted in the brain – usually in its outer layer, or cortex. There they record electrical signals from neurons. Software then “decodes” these signals, which can then be used to control a computer cursor or a prosthesis, for example.

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Neuracle Technologies’ BCI consists of a coin-sized wireless implant that sits on the surface of the brain. It is specifically designed for people with spinal cord injuries, and BCIs in general are usually designed for use by people with paralysis or other disabilities. Neuralink’s Musk has talked about one day making them available to people without health problems, but that application is further away.

One of the first (and still one of the leading) BCIs was created in the early 2000s by a research consortium called BrainGate. The device allows study participants who have been paralyzed or “locked in” due to stroke or injury to control a computer mouse and type on a virtual keyboard. Since then, other research groups have developed devices capable of similar feats.

In the US, Musk’s Neuralink has come closest to commercializing this technology, but questions about the device’s safety remain. In 2022, the Food and Drug Administration initially rejected a bid for Neuralink to test its technology in a clinical trial. A trial was finally approved the following year, and 30-year-old Noland Arbaugh, who was paralyzed below the neck, became the first user to receive a Neuralink implant. As of January this year, the company said it had 21 participants signed up for the trial period.

Other US startups, such as Synchron and Paradromics, are developing their own BCIs and are also running ongoing trials.

However, although there is compelling evidence from these clinical tests, the devices are still considered experimental. After all, installing brain implants requires brain surgery, which is highly invasive and carries the risk of infection and complications. And the implants can sometimes move or cause scar tissue to build up over time that degrades their signals. No BCI devices are approved for commercial use in the United States

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