Neuralink, the neurotechnology company founded by Elon Musk, has been granted approval by an independent review board to commence the first human clinical trials of its brain implant device. The groundbreaking news was announced in a blog post on Tuesday. The study aims to implant Neuralink’s N1 device in patients suffering from severe paralysis conditions, such as tetraplegia due to cervical spinal cord injuries or amyotrophic lateral sclerosis (ALS).
The trial, called PRIME, will span approximately six years and primarily focus on evaluating the safety of the N1 implant and Neuralink’s robotic surgery system. Utilizing the company’s surgical robot, ultra-thin and flexible brain-computer interface (BCI) threads will be implanted in a region of the brain associated with movement intention. The ultimate goal is to empower paralyzed individuals to control a computer cursor or keyboard using their thoughts.
Initially, Neuralink had planned to enroll ten patients in the study, but the US Food and Drug Administration (FDA) expressed safety concerns. While an exemption for investigational devices was granted in May, experts anticipate that it could take over a decade for commercial authorization. Despite facing federal scrutiny over its animal testing practices, Neuralink has ambitious plans for its technology, including potential applications in treating obesity and depression.
The significance of this development for Neuralink cannot be understated. It is a major breakthrough in the highly competitive brain-computer interfaces sector, where no company has yet obtained final FDA approval. Various other companies have made promising advancements in this field, but Neuralink’s progress in obtaining permission to conduct human trials sets it apart.
Under the FDA’s investigational device exemption, the PRIME study will utilize Neuralink’s robotic system to implant the N1 device. This device consists of flexible and ultra-thin threads that record and wirelessly transmit brain signals. Later, an app will decode these signals, allowing for the conversion of intentions into movement.
While this milestone marks a significant step for Neuralink, the company still faces numerous challenges on its path to commercialization. Final FDA approval is required before the device can be marketed for medical use, and regulatory hurdles will need to be overcome.
With this approval, Neuralink is poised to bring about a revolutionary change in the field of neurotechnology, offering hope to patients with severe paralysis conditions and pushing the boundaries of what is possible in terms of human-computer interface capabilities.