The Food and Drug Administration (FDA) has given Neuralink, the neurotech business co-founded by Elon Musk, permission to launch its first in-human clinical research. The Link, a revolutionary brain implant from the business, enables people with severe paralysis to command external devices through neural impulses. By allowing users to control cursors and write using their thoughts, this ground-breaking technology has the potential to help people struggling with crippling illnesses like ALS regain their ability to communicate.
Neuralink thanked the FDA in a tweet and emphasized the cooperation between the organization and its personnel. The specifics of the authorized trial have not been made public, and the clinical research has not yet started to enroll patients.
In the rapidly developing area of brain-computer interface (BCI) technology, which entails interpreting brain impulses to control external devices, Neuralink is a major participant. Neuralink has drawn a lot of interest in the business world because to its leadership by Elon Musk, who is well-known for his work with Tesla, SpaceX, and Twitter.
Although BCI technology has been the subject of much scientific research for many years and a number of businesses have made progress in creating viable systems, getting FDA certification for a commercial medical device is a difficult process that requires stringent testing and data security measures.
Patients who use Neuralink’s BCI device must have invasive brain surgery. The Link, a small, circular implant, is crucial to the translation and processing of cerebral impulses. To monitor cerebral activity, it is attached to flimsy, flexible threads that are skilfully placed into the brain tissue.
According to the company’s website, patients using Neuralink devices would learn to manage the system using the Neuralink app, allowing them to use Bluetooth to control external mouse and keyboards.
Following previous difficulties the firm has had, the FDA’s permission for an in-human trial represents a big victory for Neuralink. The U.S. Department of Transportation said in February that it was looking into allegations that Neuralink transported infected technology inadvertently packaged improperly. Also according to reports that surfaced in March, the FDA had originally denied Neuralink’s application for human trials due to a number of issues that needed to be resolved.
Additionally, Neuralink has been under fire from activist organizations for how it handles its animal testing. The Physician’s Committee for Responsible Medicine (PCRM), a group that opposes animal research, has pushed Musk to provide details about monkey trials that it claims caused major health problems and even deaths. Requests for comment have not yet gotten a response from PCRM.
BCIs have the potential to heal illnesses including blindness and mental illness in addition to helping those with paralysis, according to scientists. Musk has said that Neuralink intends to investigate these potential uses, which may include ways to raise the potential of healthy people.
Musk expressed his own interest in getting a Neuralink implant during a hiring event last year, highlighting the implant’s imperceptibility. Musk said, “You could have a Neuralink implanted right now and you wouldn’t even know. In one of these demonstrations, I really will.
