USA — Elon Musk’s pioneering neurotechnology company, Neuralink, has been granted permission by the US Food and Drug Administration (FDA) to proceed with testing and implanting its revolutionary AI brain-reading wearable device in humans as part of its upcoming clinical trial.
This significant milestone comes less than six months after the US Office of the Inspector General initiated an investigation into Neuralink’s animal welfare practices.
In a Twitter announcement, the Neuralink team expressed their delight and credited their remarkable collaboration with the FDA for this achievement.
They stated that the approval marks an essential initial step toward harnessing their technology to assist countless individuals in the future.
Although recruitment for the clinical trial is not yet open, Neuralink’s current focus lies in empowering people with quadriplegia to control computers and mobile devices through their thoughts.
Neuralink, unveiled by Elon Musk in 2019, is at the forefront of developing brain-computer interface (BCI) technology.
The company’s website showcases the “N1 Implant,” which has the potential to enable individuals to control and communicate with computers using their brain signals.
The team has already conducted successful experiments on animals, including a memorable demonstration with a monkey, and has presented prototypes resembling wireless earphones or mini-hearing aids.
Neuralink aims to enhance human capabilities and treat neurological conditions by integrating artificial intelligence and implanting electrode-fueled threads into the brain’s neurons.
But what exactly is Neuralink’s brain-computer interface? It is a Class III medical device that establishes a connection between the brain and an external computer via a Bluetooth signal, facilitating seamless communication.
The device called a Link, is roughly the size of a coin and is surgically implanted through a precise robotic procedure that creates a small disk-shaped cutout in the skull.
The Link comprises a thousand thin threads that are delicately spliced by the robot, connecting them to specific neurons in the brain. Each thread is approximately one-fourth the diameter of a human hair.
The chips within the implant read signals from the neurons, enabling the device to interpret the user’s desired commands.
With the FDA’s approval, Neuralink can now collect data on the device’s efficacy. The implant consists of 1,024 electrodes distributed across 64 threads, which meticulously record brain activity.
Neuralink’s design team emphasizes that the flexible and ultra-thin threads minimize damage during the implantation process, ensuring safety and reliability.
Potential benefits
The potential benefits of Neuralink’s technology are vast. The company’s mission is to develop a comprehensive brain interface that restores autonomy to individuals with unmet medical needs and unlocks human potential.
Aside from enabling universal communication through downloadable language, the brain-reading device has the potential to integrate with machines such as surgical robots.
The N1 Implant, which is fully implantable and virtually invisible, allows users to control computers or mobile devices anywhere they go.
Enclosed in a biocompatible case capable of withstanding physiological conditions even harsher than those within the human body, the device holds promise for precise control of prosthetic limbs, providing amputees with natural motor skills.
Furthermore, it could revolutionize the treatment of conditions like Parkinson’s disease, epilepsy, spinal cord injuries, obesity, autism, depression, schizophrenia, and tinnitus.
Other neurotechnology companies and researchers have already developed BCI technologies that have successfully assisted individuals with limited mobility in regaining movement and accomplishing daily tasks.
BCIs have also shown promise in helping older individuals maintain and enhance their motor and cognitive abilities, mitigating the adverse effects of aging.
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