Skip to content

Elon Musk’s Brain Chip Company Gets FDA Greenlight For ‘First-In-Human Clinical Study’

Neuralink gets FDA approval for human trial, a major stride in Musk's brain-implant tech vision.
Getting your Trinity Audio player ready...

Elon Musk’s brain-implant company Neuralink has received a green light from the Food and Drug Administration to commence its “first-in-human clinical study.”

This milestone achievement for Neuralink comes after a series of setbacks and challenges faced by the company in its pursuit of FDA approval.

Neuralink logo displayed on a phone screen, a silhouette of a paper in shape of a human face and a binary code displayed on a screen are seen in this multiple exposure illustration photo taken in Krakow, Poland on December 10, 2021. JAKUB PORZYCKI/BENZINGA

In a tweet, the company wrote that this was 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.”

“Recruitment is not yet open for our clinical trial. We’ll announce more information on this soon!” Neuralink added.

Elon Musk also took to Twitter to applaud Neuralink team.

“Congratulations Neuralink team,” said Musk in a tweet

He previously tweeted in November of 2022 that the company had confidence its device was ready for humans.

Twitter CEO Elon Musk speaks at the “Twitter 2.0: From Conversations to Partnerships,” marketing conference in Miami Beach, Florida, on April 18, 2023. (Photo by CHANDAN KHANNA/AFP via Getty Images)

Neuralink had faced several hurdles on its journey to gain FDA approval. Despite Musk’s repeated predictions since 2019 about starting human trials for the brain implant, the company only submitted its application to the FDA in early 2022.

The FDA raised concerns regarding the device’s lithium battery , the potential migration of the implant’s wires within the brain, and the safe extraction of the device without causing damage to brain tissue.

“If the animal testing is unreliable, then (human trial) approval may be based on flawed animal safety data. The FDA should have verified their trust of animal study results,” said Victor Krauthamer, an adjunct professor who spend 3 years with the FDA.

The FDA approval represents a crucial step forward for the field of brain-implant technology. 

The successful development and implementation of this technology could potentially revolutionize the treatment of various severe conditions, offering hope to individuals suffering from paralysis, blindness, and other disabilities.

Dina Meyer, Ice-T and Keanu Reeves in a scene from the film ‘Johnny Mnemonic’, 1995. TRISTAR/BENZINGA

Musk’s ambitious plan for Neuralink includes addressing conditions ranging from obesity, autism, depression, and schizophrenia to enabling web browsing and even telepathy.

Machines connections to the brain has been seen in the movies in the past. The was featured in two movies that starred Keanu Reeves, “The Matrix” franchise and “Johnny Mnemonic.”

Produced in association with Benzinga

Edited by Alberto Arellano and Sterling Creighton Beard

“What’s the latest with Florida Man?”

Get news, handpicked just for you, in your box.

Check out our free email newsletters

Recommended from our partners