Neuralink, Elon Musk's brain-implant company, has announced that it has received approval from the US Food and Drug Administration (FDA) to commence its first in-human clinical study. This significant milestone comes after the company faced earlier challenges in gaining approval for its groundbreaking medical device, The Guardian report stated. Neuralink aims to develop a brain implant that can treat severe conditions like paralysis and blindness.
Delays and Initial Rejection by FDA
Despite Elon Musk's predictions since 2019 regarding human trials for the brain implant, Neuralink had only recently sought FDA approval in early 2022. In March, seven current and former employees disclosed that the FDA had rejected the application due to various concerns. The agency cited issues with the lithium battery of the device, potential wire migration within the brain, and the safe extraction of the implant without damaging brain tissue.
FDA Approval and Ongoing Investigations
Notably, the FDA has now granted approval for Neuralink's clinical study, marking a significant achievement for the company. However, at the same time, US lawmakers are calling for an investigation into the composition of the panel overseeing animal testing at Neuralink, questioning whether it contributed to rushed and problematic experiments. Neuralink has already been under scrutiny, with federal investigations initiated last year to examine potential violations of the Animal Welfare Act and the USDA's oversight of the company.
Neuralink's Ambitious Vision
Elon Musk has consistently presented an ambitious plan for Neuralink over the years. In a tweet following the FDA approval, Neuralink clarified that it is not yet open for a clinical trial.
Musk envisions a future where both disabled and healthy individuals can easily receive surgical implants at local centers. These implants aim to address a wide range of conditions, including obesity, autism, depression, schizophrenia, and even enable capabilities like web browsing and telepathy.
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