The US Food and Drug Administration (FDA), which had initially rejected the application, has finally given Neuralink, Elon Musk’s brain-implant company, the green light to start its first in-human clinical study, a critical milestone after earlier struggles to gain approval.
Since 2019, Musk has predicted several times that his medical device company would begin human trials for a brain implant to treat severe conditions like paralysis and blindness.
Yet the company, founded in 2016, only sought FDA approval in early 2022 – and the agency rejected the application, seven current and former employees told Reuters in March.
The FDA had pointed out several concerns to Neuralink that needed to be addressed before sanctioning human trials, according to the employees.
These involved the device’s lithium battery, the possibility of the implant’s wires migrating within the brain, and the difficulty of safely extracting the device without damaging brain tissue.
The Guardian reports that the approval comes as US lawmakers are urging regulators to investigate whether the makeup of a panel overseeing animal testing at Neuralink contributed to botched and rushed experiments.
Neuralink has already been the subject of federal investigations.
Last year, at the request of a federal prosecutor, the USDA’s Inspector-General began investigating potential violations of the Animal Welfare Act, which governs how researchers treat and conduct tests on animals. In its experiments, the company has killed about 1 500 animals, including more than 280 sheep, pigs and monkeys, since 2018, Reuters previously reported.
The inquiry has also been looking at the USDA’s oversight of Neuralink.
Over the years, Musk has publicly outlined an ambitious plan for Neuralink, saying last year he was already so confident in the device’s safety that he would be willing to implant them in his own children.
He envisions both disabled and healthy individuals swiftly getting surgical implants at local centres.
The devices aim to cure various conditions, from obesity, autism and depression to schizophrenia, and enabling web browsing and telepathy.
See more from MedicalBrief archives:
Step forward in human studies for Neuralink brain implants
First human trial: Tiny device translates thought into action
Novel brain implant may lift treatment-resistant depression