News & Analysis

Musk's Neuralink given FDA approval for human studies

26th May 2023
Kristian McCann

Elon Musk's Neuralink has been given a green light by the FDA to begin studies on humans.

Neuralink said in a statement on Thursday it had won the approval of the US governmental body "to launch our first-in-human clinical study!" And how the move represents "an important first step that will one day allow our technology to help many people."

Musk, who last year claimed the devices were so safe he would happily use his children as guinea pigs, believes this technology will go on to help physical conditions like obesity, autism, depression and schizophrenia, as well as allowing a deeper integration between humans and technology, by enabling internal web browsing, telepathic communication between implanted individuals, and even assuage human worries about being displaced by AI. The microchips, that have previously been tested in monkeys, are designed to interpret signals produced in the brain and relay information to devices via Bluetooth.

This approval comes after years of setbacks the brain chip firm received from the administration. The billionaire has previously said Neuralink would begin human trials at least four times since 2019, but the company only applied for its first FDA approval to progress to human trials early last year, which was rejected over “major safety concerns”.

The concerns were raised over the implant's lithium battery, the possibility of its wires migrating within the brain, and whether the device could be safely removed without damaging brain tissue. The FDA said these concerns needed to be addressed before the sanctioning of human trials. The regulator has yet to comment on the decision.

Despite the long-awaited approval, the company did not immediately elaborate on any of the aims of the study, dates of the trials, or even when volunteer recruiting will start. However, reports from earlier this year highlight how it had been in talks with a number of medical centres – including the Barrow Neurological Institute in Arizona – to help them carry out the human trials.

Since Neuralink’s founding in 2016, the company has been the subject of several federal investigations. Last year it reportedly came under investigation for alleged animal welfare violations, with many of the 1,500 animal’s deaths being internally accredited to rushed testing.

The potential this technology can bring forth was highlighted this week when Swiss researchers helped a paralysed man from the Netherlands to walk simply by thinking about it thanks to a system of similar implants.


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