CALIFORNIA – Elon Musk has predicted that his medical device business, Neuralink, will shortly begin human trials of a ground-breaking brain implant to treat untreatable conditions like paralysis and blindness at least four times since 2019.
However, the business, which was established in 2016, didn’t apply for approval from the US Food and Drug Administration (FDA) until early 2022,
And the FDA rejected the request, according to seven current and former employees who were quoted by Reuters.
The rejection hasn’t previously been disclosed.
The decision was communicated to Neuralink along with a long list of issues that needed to be resolved before testing on humans, a crucial step toward final product approval, according to the staff.
The implant’s lithium battery, the potential for the tiny wires to spread to other parts of the brain, and the possibility that the device could be removed without harming brain tissue were the three main safety worries for the agency, according to the employees.
Neuralink is still working through the agency’s worries a year after the rejection. Despite Musk‘s most recent prediction that the firm would obtain FDA human-trial certification this spring at a presentation on Nov. 30, three employees said they were doubtful the company could swiftly fix the issues.
The specifics of Neuralink’s trial proposal, the FDA’s rejection, or the scope of the agency’s concerns have not been made public.
It is not necessary to disclose such regulatory encounters to investors since it is a private business.
Musk claimed, without elaborating, that the company had submitted “most of our paperwork” to the FDA during the lengthy presentation in November,
Additionally, representatives of the company admitted that the FDA had questioned its safety during what they described as an ongoing discussion.