Neuralink said on Twitter yesterday:
“We are excited to share that we have received the FDA’s approval to launch our first-in-human 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.
Recruitment is not yet open for our clinical trial. We’ll announce more information on this soon!”
In a statement provided by a spokesperson, the FDA said: “The FDA acknowledges and understands that Neuralink has announced that its investigational device exemption (IDE) for its implant/R1 robot was approved by the FDA and that it may now begin conducting human clinical trials for its device.”
Citing anonymous current and former employees, Reuters has reported that the FDA previously rejected a Neuralink application for human clinical trials in early 2022.
During a Nov. 30, 2022 show and tell, Musk said that Neuralink would have the first-in-human implant of its N1 device within the next six months.
During the show and tell, Musk discussed an implant called the N1 that is about the size of a coin. It’s rechargeable remotely and goes along with electrode-laced threads that go further into the brain. In addition, Neuralink has an R1 robot that’s supposed to be programmed to implant the BCI system while avoiding vasculature.
Musk, in November, said the Neuralink team was busy improving and miniaturizing the system.
Brain-computer interfaces are a hot space. (Here are seven companies you need to know.) For example, Blackrock Neurotech has a next-gen BCI — called Neuralace — that visually looks like a piece of lace. It is thinner than an eyelash.
Meanwhile, Bill Gates and Jeff Bezos are among those investing in Synchron and its stent-like Stentrode that is implanted through a minimally invasive endovascular procedure.