US FDA reportedly denies Neuralink approval to conduct human trials

(Image: Neuralink)

The United States Food and Drug Administration (FDA) has reportedly denied approvals for human trials to brain-computer interface (BCI) startup, Neuralink.

According to Reuters, current and former employees of Elon Musk's brain implant startup told the publication that the FDA's primary concerns, "involved the device’s lithium battery; the potential for the implant’s tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue."

Also Read | Jeff Bezos, Bill Gates-backed startup tests brain implant that can control technology

The FDA is also seeking assurance that the battery within the implant will not fail, because if it does, it could mean potentially harmful consequences for the implantee.

Sources told Reuters that if the device fails, there is potential for an electricity or heat energy leak that could damage tissue.

Last year in December, Elon Musk held a show and tell for Neuralink where he unveiled the N1 brain implant. The company showed a demo of a monkey with the N1 chip being able to control a mouse cursor with his mind.

At the event, Musk claimed the company was five to six months away from FDA approval for human trials.

Neuralink was already under fire by various animal welfare groups that claimed the company mistreated animals.

Also Read | All about the brain implant by Neuralink, Elon Musk’s company facing animal cruelty accusations

Several employees from within the company have spoken out against Musk's erratic nature, claiming the CEO was forcing them to accelerate development, resulting in critical failures and unneeded deaths of the animal subjects.

In a previous report by Reuters, the publication managed to unearth documents that confirmed the company had killed 1500 animals during testing.

“He can’t appreciate that this is not a car,” one employee told Reuters. “This is a person’s brain. This is not a toy.”