With approval from the US Food and Drug Administration (FDA) to begin its first-in-human clinical research, Neuralink, the brain implant business founded by Elon Musk, has accomplished a key milestone. With past difficulties securing regulatory permission, this approval represents a significant turning point for Neuralink.
The human trials of Neuralink's brain implant, which has the ability to treat serious illnesses including paralysis and blindness, have been anticipated by Musk since 2019. Nevertheless, despite the company's founding in 2016, the FDA clearance procedure wasn't started by Neuralink until early 2022. Sadly, the agency turned down their application, according to information provided to Reuters in March by seven current and former workers.
The employees disclosed that the FDA had flagged a number of issues that needed to be addressed before authorising human studies. These worries were on the implant's lithium battery, the potential for wire migration inside the brain, and the safe removal of the device without harming brain tissue.
The FDA's recent approval arrives amidst growing pressure from US lawmakers urging regulators to investigate potential issues with the panel overseeing animal testing at Neuralink, which may have led to rushed and flawed experiments. Neuralink has already been the focus of federal investigations, with the Inspector General of the US Department of Agriculture looking into potential Animal Welfare Act violations at the request of a federal prosecutor.
Neuralink stated in a tweet that while the FDA's approval is a big step forward, it is not yet ready for a clinical trial. The business praised the FDA for its cooperation and emphasised the significance of this achievement in laying the groundwork for the widespread use of their technology in the future.
Elon Musk established the neurotechnology business Neuralink in 2016. Its main objective is to create implantable brain-computer interfaces (BCIs) that can establish a direct link between computers or other external equipment and human brains. The goal of the company is to combine human intelligence with artificial intelligence in order to improve human cognition and maybe lessen neurological disorders.
The brain implants made by Neuralink, often known as "neural lace," are made of tiny, flexible threads that are injected into the brain together with electrodes. These threads enable the recording and activation of brain activity at great resolution. Wireless transmission of the brain's data to outside devices for analysis or control is possible.
The technology developed by Neuralink has numerous possible uses. It attempts to help people who suffer from neurological disorders like paralysis, spinal cord injuries, and various sensory impairments.
Neuralink aims to restore lost capabilities and raise general quality of life by creating a direct interface between the brain and outside technologies. Neuralink also sees a time when its brain-computer interfaces will make it possible for robots and people to communicate without any interruptions. This entails developing cognitive skills, accelerating information processing, and enabling direct connection with computers or virtual worlds
