Neuralink receives FDA approval for first-in-human brain chip clinical study

June 16, 2023


facebook icon facebook icon

On the 25th of May, 2023, Neuralink, Elon Musk’s brain implant company announced, via Twitter, that it had received the FDA’s approval to launch its first-in-human clinical study.

The announcement marked a critical milestone for the company that was formed to “create a general-purpose high-bandwidth interface to the brain”.

Neuralink, since its quiet inception in 2016, has aimed to directly interface humans with computers, using a ‘brain chip’ – a “Fitbit for your skull” if you will.

This device uses neural lace – an ultra-thin mesh made of 1024 electrodes, distributed across 64 threads – to eavesdrop on the brain (record neural activity). And, neurotech companiesexpect that this interface could help treat neurodegenerative disorders and repair other human cognitive or sensory-motion functions.

Curiously enough, Neuralink’s FDA approval comes after a previous rejection earlier this year, and a mere 6 months after a federal investigation, for “potential animal welfare violations”, ensued.

The FDA went a step further toconfirm its approval for Neuralink’s human trials and surgical robot, something the agency doesn’t typically do. However, beyond a statement of approval, it did not provide any further information.

Following Neuralink’s FDA approval announcement, we conducted a poll for HackerNoon’s 4M+ monthly visitors to gauge their stance on testing Neuralink’s implants on human brains.


As the image above shows, a 36% majority prefer to wait for more information before forming an opinion.

34% expressed a lack of support for Neuralink’s tests on humans, citing ethical concerns and concerns about resource allocation.

The leftover 27% seemed to strongly support Neuralink and emphasized the potential benefits of this groundbreaking technology.

The full Poll result can be foundhere.

Musk and Co are not the first to attempt a direct merger between humans and computers in the “real world”. In fact,  the history of brain-computer interfaces goes as far back as 1924 when Hens Berger discovered electrical activity in the human brain. This then led to the concept of electroencephalography (EEG) – recording an electrogram of the spontaneous electrical activity of the brain.

Since Berger’s monumental discovery, scientists have expended a lot of effort trying to interact with the brain’s uncanny electricity.

In 1973, Vidal Jacques, after 2+ years of research at UCLA and under a grant from the National Science Foundation, broke the ice with the first mention of a “Brain-Computer Interface” inscientific literature.

Fast forward to the early 2000s: John Donoghue and colleagues at Brown University develop the BrainGate System. which allowed a paralyzed individual to control a computer cursor and perform simple tasks using implanted electrodes.

Then in 2006,Miguel Nicolelis and his team at Duke University demonstrated the ability of monkeys to control a virtual arm using a BCI and successfully operate a robotic arm using brain signals.

A mere 4 years ago, in 2019, Researchers at the University of California, San Francisco, developed a speech neuroprosthesis that enabled a man with severe speech paralysis to communicate in sentences. A testament to sustained and extensive research efforts in the field of BCI.

In 2020, as the pandemic raved on, Neuralink unveiled its first implanted BCI device, showing progress in miniaturization and wireless communication. The following year the company released a demo video of Pager, a 9-year-old  (at the time) test monkey playing video games with its brain.


Neuralink is not the only company working to connect us with machines, or even the most advanced.

As Columbia Neurobiologist, Rafael Yuste, told Forbes:

Brain implants for conditions like Parkinson’s disease are already in widespread use and similar firms like Blackrock Neurotech and Synchron have already started human tests, the former decades ago.

Nonetheless, the company receives the most media attention and funding because of its connection to everybody’s “favorite” billionaire – Elon Musk.

According to a report by Reuters, Neuralink, previously valued at $2 Billion in a private funding round 2 years ago, is now worth $5 Billion based on privately executed stock trades.

Alas, Musk’s significant involvement in Neuralink looks to be a two-edged sword, as the same connection that attracts funding appears to fan the flames of ethical concern – just as one of the comments to the HackerNoon poll expressed:


What do YOU think?

Please share your thoughts in the comments and look out for other Technology polls by HackerNoon.

This article was originally published by Asher on Hackernoon.


facebook icon facebook icon

Sociable's Podcast