Elon Musk’s brain implant company, Neuralink, announced Thursday that it has received the green light from the Food and Drug Administration (FDA) to begin human trials.
On at least four occasions since 2019, Musk has predicted that his medical device company will begin human trials for brain implants to treat serious conditions such as paralysis and blindness.
However, the company, which was founded in 2016, only sought FDA approval in early 2022, and the agency rejected the request, seven employees told Reuters.
Neuralink had flagged several concerns with the FDA that needed to be addressed before they could begin human trials, according to employees. The main issues involved the device’s lithium battery, the possibility of implanted wires migrating into the brain, and the challenge of carefully removing the device without damaging brain tissue.
Thursday’s FDA approval comes as U.S. lawmakers are urging regulators to investigate whether the composition of the board that oversaw animal testing at Neuralink contributed to increased and invasive testing.
Neuralink is already the subject of federal investigations
Reuters reported last December that the U.S. Department of Agriculture’s inspector general had asked the federal prosecutor for possible violations of the Animal Welfare Act, which governs how researchers handle and test certain types of animals.
The investigation also focuses on the oversight of Neuralink by the United States Department of Agriculture.
Over the years, Musk has publicly emphasized Neuralink’s ambitious project. For the next year he was so confident of his plans of safety that he wanted to pass them on to his children.
MOSCOW ensures that both disabled and able-bodied people can quickly get implant surgery at local centers. These devices aim to cure various conditions, from obesity, autism, depression, schizophrenia, to web feeding and telepathy.
“We are pleased to announce that we have received FDA approval to conduct the first human clinical study!” Neuralink celebrated on their social media.
He also confirmed that this is the result of the work carried out by the Neuralink team in close collaboration with the FDA, and it represents the first important step that will one day allow their technology to help many people.
It indicates that recruitment is a candidate for clinical trials not yet open.
(In data from Reuters)