• Neuralink confirms that it has received approval from the FDA to launch its first human clinical trial.
• The approval comes after being initially denied in March this year.
• Neuralink says that recruitment for the clinical trial is not yet open, but it will communicate this information in the coming weeks.

Late last year Elon Musk’s wildly ambitious and divisive Neuralink provided an update on its plans to combat neurological diseases with sophisticated brain implants. At the time all testing was done on animals, but Musk said human trials were six months away.

While initially denied the request for human clinical trials by the Food and Drug Administration Stateside in March this year, FDA approval has now been received.

Neuralink confirmed the news in a tweet from its official account, noting that, “We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!”

At the time of writing it remains to be seen if this FDA approval is indeed the go-ahead that Neuralink needs to commence human clinical trials, especially as other US regulators and organisations will likely want to weigh in on this project too.

Added to this is a report from Reuters earlier this year in which the FDA cited several issues with Neuralink’s testing and the potential impact it would have on a human subject. Added to this were accounts from former Neuralink employees regarding the methods used by the company and red flags that would be raised should it ever reach readiness for human testing.

With no comment or further information shared by the FDA at this time, it is unclear if Neuralink adequately addressed those concerns raised earlier.

For now, despite FDA approval, Neuralink says applications are not yet open for those interested in clinical trials, but it will communicate such plans soon.

Our only question at this stage is who would be willing to engage in such a test given how things have gone to date.

[Image – Photo by Natasha Connell on Unsplash]