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FDA Nods at Musk's Neuralink for Pioneering Human Trials

Published 2023-09-19, 07:37 p/m
© Reuters.  FDA Nods at Musk's Neuralink for Pioneering Human Trials
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Quiver Quantitative - Elon Musk's (TSLA) pioneering venture, Neuralink, has recently secured the green light from an independent review board to initiate the inaugural human trial phase for its innovative brain implant, specifically designed to assist individuals suffering from paralysis. This ambitious project aims to enable participants, particularly those afflicted with cervical spinal cord injuries or amyotrophic lateral sclerosis, to control a computer cursor or keyboard merely with their thoughts. Although the exact number of participants remains undisclosed, the trial period is projected to span approximately six years, involving the utilization of a robot to surgically implant a brain-computer interface (BCI) in the brain area governing movement intentions.

In the pursuit of finalizing the participant count, Neuralink has been in ongoing discussions with the U.S. Food and Drug Administration (FDA), following initial proposals to incorporate ten patients in the study. This adjustment in the participant number comes after the FDA expressed safety concerns regarding the procedure, prompting a negotiation to potentially decrease the number of individuals involved. Despite these hurdles, Musk envisions a broad spectrum of applications for Neuralink's technology, proposing its potential efficacy in addressing a range of conditions including obesity, autism, and mental health disorders such as depression and schizophrenia.

Earlier this year, Neuralink announced that it had obtained FDA clearance to commence its first human clinical trial, even amidst scrutinization regarding its approach to animal testing. This approval marked a significant milestone for the company, setting the stage for it to potentially revolutionize treatment approaches for a variety of medical conditions. Musk's grand vision for Neuralink extends beyond its initial focus, anticipating the facilitation of rapid surgical procedures to implant the chip devices, thereby potentially transforming the healthcare landscape.

However, despite the promising prospects, industry experts caution that the journey towards commercial utilization of the BCI device remains a long-term endeavor. Assuming the device is validated as safe for human application through the upcoming trials, the pathway to secure clearance for commercial use is anticipated to span over a decade. This suggests a considerable waiting period before the technology can potentially become accessible to the broader population, marking the beginning of a new era in medical technology and treatment methodologies.

This article was originally published on Quiver Quantitative

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