First human trial for neuralink brain implant approved by FDA

Elon Musk’s Neuralink, a brain-implant startup dedicated to furthering the advancement of neurotechnology, has reached a critical milestone. The company took to Twitter on May 25 to report that Neuralink has received approval from the U.S. Food and Drug Administration (FDA) to launch the first ever human trial for brain implants.

“We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!” The company said on Twitter. “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.”

But while Neuralink begins preparing for the recruitment phase of the human clinical trials, the company is also under investigation by the U.S. Department of Agriculture and the the Department of Transportation. According to a Reuters report, Neuralink rushed and ultimately botched several surgeries on animals as a result of pressure from Musk to receive FDA approval as quickly as possible.

In one 2021 instance alone, the company reportedly killed 25 pigs by implanting the wrong size devices in their brains. Employees told Reuters that the incident, which lead to the death of all 25 pigs, could have been easily avoided with more preparation. The company has also botched surgeries on monkeys and sheep, leading to more unnecessary animal deaths.

“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,” Victor Krauthamer, an adjunct biomedical engineering professor who spent three decades at the FDA, told Reuters.

The brain implants might someday treat a number of conditions, including obesity, autism, depression and schizophrenia. Musk has also shown an interest in the implants enabling web browsing and telepathy.