Neuralink receives FDA approval for human trial of brain-implant device

Neuralink, Elon Musk’s brain-implant firm, announced that the US Food and Drug Administration (FDA) had given approval for its first human clinical trial. Although the company did not provide details on the study’s goals, it stated that it was an essential first step towards assisting many people.

Neuralink envisions the use of brain implants to treat a wide range of conditions, including autism, obesity, depression, and schizophrenia, while also enabling functions like web browsing and telepathy. It is part of an emerging field of brain-computer interface (BCI) technology. BCIs are systems that interpret brain signals and translate them into commands for external devices. Over the years, scientists have extensively studied BCI technology, and several companies have developed promising systems with hopes of bringing them to market.

Despite Elon Musk’s reassurances, the FDA initially rejected Neuralink’s application in early 2022 due to various concerns that needed to be addressed before human trials could be authorised. According to current and former employees, these concerns primarily revolve around the lithium battery, the potential migration of the implant’s wires within the brain, and the challenge of safely removing the device without causing damage to the brain tissue.

Neuralink has been the subject of various federal inquiries, with US lawmakers requesting regulators to investigate whether flaws in the oversight of animal testing at the firm contributed to rushed and botched experiments. The Department of Transportation is also probing Neuralink for allegedly illegally transporting dangerous pathogens on chips taken out of monkey brains without proper containment measures. Additionally, the US Department of Agriculture’s Office of Inspector General is investigating the brain-implant firm for alleged violations of animal welfare regulations and the USDA’s oversight of Neuralink.