Neuralink, the brain-implant company founded by Elon Musk, has achieved a significant milestone with the green light from the US Food and Drug Administration (FDA) to commence its first-in-human clinical study. This approval marks a critical turning point for Neuralink, which faced earlier challenges in obtaining regulatory clearance.

Since 2019, Musk had expressed his anticipation for human trials of Neuralink’s brain implant, which holds the potential to address severe conditions like paralysis and blindness. However, despite the company’s establishment in 2016, it wasn’t until early 2022 that Neuralink initiated the process for FDA approval. Regrettably, the agency rejected their application, according to information shared by seven current and former employees with Reuters in March.

The FDA had raised several concerns that needed to be resolved before granting authorisation for human trials, as revealed by the employees. These concerns revolved around the lithium battery of the implant, the potential migration of wires within the brain, and the safe extraction of the device without causing damage to brain tissue.

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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 subject of federal probes, with the US Department of Agriculture’s Inspector General conducting an investigation into possible violations of the Animal Welfare Act at the request of a federal prosecutor. The probe has also scrutinised the USDA’s oversight of Neuralink.

While the FDA’s approval is a significant step forward, Neuralink clarified in a tweet that it is not yet ready for a clinical trial. The company acknowledged the collaborative efforts between its team and the FDA, emphasising the importance of this milestone in paving the way for their technology to benefit numerous individuals in the future.

What is Neuralink?

Neuralink is a neurotechnology company founded by Elon Musk in 2016. Its primary goal is to develop implantable brain-computer interfaces (BCIs) that can establish a direct connection between the human brain and computers or other external devices. The company’s vision is to enhance human cognition and potentially mitigate neurological disorders by merging human intelligence with artificial intelligence.

Neuralink’s brain implants, often referred to as “neural lace,” consist of tiny, flexible threads embedded with electrodes that are inserted into the brain. These threads allow for high-resolution recording and stimulation of neural activity. The data gathered from the brain can be transmitted wirelessly to external devices for analysis or control.

The potential applications of Neuralink’s technology are wide-ranging. It aims to assist individuals with neurological conditions, such as paralysis, spinal cord injuries, and various forms of sensory impairment. By establishing a direct connection between the brain and external devices, Neuralink seeks to restore lost functionalities and improve the overall quality of life.

Furthermore, Neuralink envisions a future where its brain-computer interfaces enable seamless communication between humans and machines. This includes enhancing cognitive abilities, facilitating faster information processing, and enabling direct interaction with computers or virtual environments.

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