Neurotech startup co-founded by Elon Musk, Neuralink has obtained approval from the Food and Drug Administration (FDA) to commence its first in-human clinical study.
The neurotech company is currently developing a brain implant called the Link, with a primary objective of helping individuals suffering from severe paralysis to control external technologies solely through neural signals.
This technology holds the potential to restore communication abilities for patients affected by degenerative diseases such as ALS. If successful, these patients could regain their ability to interact with their loved ones by moving cursors and typing through their thoughts.
The company tweeted, “This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people.”
We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!
— Neuralink (@neuralink) May 25, 2023
This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our…
And although the extent of the approved trial remains unknown, Neuralink also says that it is not currently recruiting patients for clinical trials yet.
A significant milestone
Neuralink operates within the growing field of brain-computer interfaces (BCIs). BCIs are systems designed to interpret brain signals and convert them into commands for controlling external technologies. This emerging industry focuses on developing technologies that bridge the gap between the human brain and various devices, enabling direct communication and interaction through neural activity.
While no other BCI company has been able to obtain the final approval from the FDA, Neuralink has taken a significant stride towards entering the market by securing approval for a study involving human patients. It’s a milestone that brings the company one step closer to making its technology commercially available.
However, CNBC reported that Neuralink has come under fire from activist groups due to its alleged treatment of animals. The Physicians Committee for Responsible Medicine, an organisation that advocates against animal testing, has consistently urged Musk to disclose information regarding experiments conducted on monkeys, which reportedly led to distressing outcomes such as internal bleeding, paralysis, chronic infections, seizures, deteriorating psychological health and even death.
During a ‘Show and Tell’ recruitment event held last year, Musk went as far as stating his intention to personally receive one of Neuralink’s implants in the future, “You could have a Neuralink device implanted right now and you wouldn’t even know. In fact, in one of these demos, I will.”

Isa Muhammad is a writer and video game journalist covering many aspects of entertainment media including the film industry. He's steadily writing his way to the sharp end of journalism and enjoys staying informed. If he's not reading, playing video games or catching up on his favourite TV series, then he's probably writing about them.
