Neuralink Secures FDA Approval to Begin Human Trials for Brain Chip

Neuralink, the neurotechnology company founded by tech billionaire Elon Musk, has received approval from the United States Food and Drug Administration (FDA) to begin its first human trials for a brain-computer interface (BCI) device known as the Link.

The approval marks a significant milestone for the California-based company, which has long touted its vision of merging humans with machines to treat neurological conditions and, eventually, enhance human capabilities.

The device, no larger than a coin, is surgically implanted into the skull.

It connects to the brain via ultra-thin threads, thinner than a human hair, which target specific regions associated with movement and speech.

Neuralink says the aim is to enable people with paralysis or speech impairments to control external devices, such as a phone or computer, simply by thinking.

In a statement posted on X (formerly Twitter), Neuralink confirmed: "We are excited to share that recruitment is now open for our first-in-human clinical trial." The study will focus on individuals suffering from quadriplegia due to spinal cord injury or ALS (amyotrophic lateral sclerosis).

Musk has previously claimed that the technology could one day restore sight to the blind, enable telepathic communication, and even allow humans to compete with artificial intelligence.

However, these bold visions have been met with both intrigue and scepticism.

Dr. Caroline Peterson, a neuroethics expert at the University of Oxford, cautioned: “While this development is impressive, it raises significant ethical questions. We must ensure that the technology does not outpace regulation, especially when dealing with the human brain.”

This is not Neuralink’s first attempt to secure FDA approval.

The company’s initial application was rejected in early 2022 over safety concerns related to battery design and the potential for brain tissue damage.

The latest greenlight indicates that Neuralink has since addressed those concerns to the satisfaction of the regulatory body.

Although still in its early stages, the human trials represent a crucial step toward commercialising BCI technology.

Neuralink is one of several companies racing to bring brain-computer interfaces to market.

Others, including Synchron and Precision Neuroscience, are exploring less invasive approaches.

If successful, Neuralink’s chip could redefine how humans interact with machines, blurring the line between biology and technology in ways once thought to be science fiction.