Elon Musk’s brain implant company, Neuralink, announced on Thursday that the Food and Drug Administration (FDA) has given the go-ahead for it to start conducting its first in-human clinical research. This is a significant achievement after Neuralink’s past difficulties in obtaining approval for its products.
Since the beginning of 2019, Musk has said at least four separate times that his business, which manufactures medical devices, would soon begin testing a brain implant on humans in order to cure serious illnesses like blindness and paralysis.
However, the business, which was established in 2016, did not apply for FDA permission until the beginning of 2022; the agency did not accept the application, according to seven current and former workers who spoke to Reuters in March.
According to the workers, the FDA had expressed a number of issues with Neuralink that needed to be resolved prior to the company being granted permission to conduct human trials. The lithium battery of the device was a major concern, as was the potential for the wires of the implant to migrate inside the brain, as well as the difficulty of properly removing the device without causing damage to brain tissue.
The certification by the FDA on Thursday comes at a time when senators in the United States are pushing for an investigation into whether the composition of a panel that oversaw animal testing at Neuralink led to botched and hurried trials.
Investigations into Neuralink have previously been conducted by the federal government.
In response to a request from a federal prosecutor, the inspector general of the USDA opened an investigation into possible breaches of the Animal Welfare Act in 2018. This law dictates how researchers are required to handle and experiment on certain species of animals. According to a recent report by Reuters, the corporation has been responsible for the deaths of over 1,500 animals as a result of tests since 2018. This number includes more than 280 sheep, pigs, and monkeys.
The supervision of Neuralink by the USDA has also been investigated as part of this examination.
Neuralink said in a tweet on Thursday that it is not currently accepting patients for a 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 technology to help many people,” the company said in a tweet on Thursday.
Musk has, over the course of many years, provided the world with an overview of an ambitious plan for Neuralink. Late in the previous year, he made headlines when he said that he was already so convinced of the safety of the device that he would be prepared to implant them in his own children if he thought it was necessary.
Musk anticipates both impaired and healthy people being able to acquire surgical implants at local centres in a short amount of time. These machines are designed to treat a wide variety of illnesses, such as obesity, autism, depression, and schizophrenia, in addition to facilitating online surfing and telepathy.