STORY: Elon Musk's brain-implant company Neuralink said on Thursday it had been given a green light from the U.S. FDA to kickstart its first-in-human clinical study.
It’s a critical milestone for Neuralink after earlier struggles to gain approval.
On at least four occasions since 2019, Musk has said his medical device company would begin human trials for a brain implant to treat severe conditions such as paralysis and blindness.
Yet the company only sought Food and Drug Administration approval in early 2022.
And the agency rejected the application, sources linked to the company told Reuters in March.
The sources said the FDA had pointed out several concerns to Neuralink that needed to be addressed before sanctioning human trials.
They include the device’s battery as well as safety issues surrounding its wires and the protection of brain tissue.
Thursday's FDA approval comes as U.S. lawmakers are urging regulators to investigate the oversight of animal testing at Neuralink.
The company has already been the subject of federal probes, including at least one linked to animal testing and treatment.
In a tweet on Thursday, Neuralink said it was “excited” to share the news of the approval, but that it’s not yet recruiting for a clinical trial.
Over the years, Musk has publicly outlined an ambitious plan for Neuralink.
He envisions its devices to cure a range of conditions from obesity, autism, depression, schizophrenia, to enabling web browsing and even telepathy.
And that both disabled and healthy individuals would be swiftly getting surgical implants at local centers.
Neuralink and the FDA did not immediately respond to a Reuters request for comment.