Neuralink, the neurotech startup co-founded by Elon Musk, has received approval from the Food and Drug Administration (FDA) to conduct its first-in-human clinical study. Neuralink aims to develop a universal brain interface that not only restores autonomy to individuals with current medical needs but also unlocks the vast potential of the human mind in the future.
The approval marks a significant milestone for the company, which is focused on developing a brain implant called the Link. The Link aims to assist patients with severe paralysis in controlling external technologies using neural signals, allowing them to regain the ability to communicate through movements and typing with their minds.
As reported by CNBC, the FDA’s approval for the study is an essential step for Neuralink in bringing its technology to market. While other brain-computer interface (BCI) industry companies have developed sound systems, none have received final FDA approval for commercial medical devices. Neuralink’s success in securing approval for a study with human patients brings it closer to achieving this goal.
Neuralink’s BCI system requires invasive brain surgery, with a small circular implant called the Link processing and translating neural signals. Thin, flexible threads inserted directly into the brain tissue detect these signals. Patients with Neuralink devices will learn to control them using the Neuralink app, enabling them to operate external devices such as mice and keyboards via Bluetooth.
The approval from the FDA follows a series of recent challenges for Neuralink. In February, the company faced an investigation by the U.S. Department of Transportation regarding the alleged unsafe packaging and transportation of contaminated hardware. In March, the FDA reportedly rejected Neuralink’s application for human trials, highlighting numerous issues the company needed to address.
Neuralink has also faced criticism from activist groups concerning its treatment of animals. The Physician’s Committee for Responsible Medicine has called on Musk to disclose details about experiments involving monkeys, citing concerns about internal bleeding, paralysis, chronic infections, seizures, declining psychological health, and death. However, Neuralink has not responded to these allegations.
Apart from assisting patients with paralysis, experts believe BCIs could potentially help treat conditions such as blindness and mental illness in the future. Musk has expressed his intentions for Neuralink to explore these applications and potential uses for healthy individuals. Musk himself has stated that he plans to receive one of Neuralink’s implants.