Neuralink, Elon Musk's brain-implant company, said on Thursday it had received a green light from the US Food and Drug Administration (FDA) to kickstart its first in-human clinical study, a critical milestone after earlier struggles to gain approval. Musk has predicted on at least four occasions since 2019 that his medical device company would begin human trials for a brain implant to treat severe conditions such as 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. Major issues involved the lithium battery of the device, the possibility of the implant's wires migrating within the brain and the challenge of safely extracting the device without damaging brain tissue.
Elon Musk's Nueralink will not be testing its brain implant on humans anytime soon - the US Food and Drug Administration (FDA) has rejected the company's application. The agency outlined dozens of issues the company must address before human testing, a critical milestone for final product approval, Neuralink staffers told Reuters. The concerns include the device's lithium battery; the potential for the implant s tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue, the employees said. Musk applied in early 2022, but staffers said the company co-founder has yet to solve all the problems - even though the billionaire revealed human trials would start in six months back in November. Three staffers said they were skeptical the company could quickly resolve the issues.
Elon Musk's Neuralink has begun recruiting for a clinical trial director, bringing it one step closer to developing technology that could connect the human mind directly to devices. Neuralink's goal is to build something called a "brain computer interface" that allows people to transmit and receive information between their brain and a computer wirelessly, according to Neuralink's website. For instance, a paralyzed person with a Neurlink chip implanted in their brain could control a mouse and keyboard without moving their limbs. Information could also be transmitted the other way and allow the person's brain to simulate the sense of touch. Neurons in the brain generate electric signals, and electrodes placed nearby neurons can capture and record those signals. While the technology is much more complex, in a simple sense, replaying these signals can simulate the actual sensation of different experiences, such as holding an apple or kissing another person.
United States regulators have given approval for Elon Musk's start-up Neuralink to test its brain implants on people. Neuralink said on Thursday that it received clearance from the US Food and Drug Administration (FDA) for the first human clinical study of implants which are intended to let the brain interface directly with computers. "We are excited to share that we have received the FDA's approval to launch our first-in-human clinical study," Neuralink said in a post on Twitter – which is owned by Musk. Neuralink prototypes, which are the size of a coin, have so far been implanted in the skulls of monkeys, demonstrations by the startup showed. With the help of a surgical robot, a piece of the skull is replaced with a Neuralink disk, and its wispy wires are strategically inserted into the brain, an early demonstration showed.
Just today, Elon Musk presented the long-awaited Neuralink: a brain interface device cable of connecting AI with your brain. This article is an extract of the presentation found on Youtube. Although this is an area of great interest, no one, up to now, has never been able to boost cognitive performances (many claims that are possible to increase your IQ, no claim has ever shown validity). Unfortunately, there is no workaround, you will need to undergo a very fast surgery (1 hour top) to install Neuralink in your brain. So far, this is the least invasive device developed by Elon Musk's team.