Neuralink Gets FDA's Approval to Launch Its First-in-Human Clinical Study

Elon Musk's brain-computer interface company Neuralink announced that it had received approval from the U.S. Food and Drug Administration (FDA) to conduct its first-in-human clinical study.

We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!

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…
— Neuralink (@neuralink) May 25, 2023

Receiving FDA approval "represents an important first step that will one day allow our technology to help many people," Neuralink said in a tweet.

There are no details yet about the planned study. The company only noted that it hasn't begun recruiting participants for the trial yet, but more information will be available soon.

Getting FDA approval for a commercial medical device is a challenging task. In March 2023, Reuters reported that the FDA did not allow Neuralink to test their brain chip implants in humans. The regulator outlined dozens of safety issues that the company needed to resolve before moving forward.

FDA Rejects Neuralink’s Request to Test Brain Chip Implants in Humans

While the sources declined to give Reuters the FDA’s written denial, explaining it was a confidential document, they described the features of the devices that caused the regulator’s concerns.

Recorded News — Tech NewsBradley Rhodes

Major safety concerns involved the battery system of the device, the potential that the tiny wires of the implant could migrate to non-targeted areas of the brain, and questions over how and if the device can be removed without damaging the human brain.

In late 2022, Elon Musk also announced that the company would receive FDA approval and begin human trials within six months – that is, by the spring of this year.