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Lawmaker Queries FDA Over Neuralink Inspection

March 27, 2024

In recent developments, U.S. Representative Earl Blumenauer, deeply embedded in health policy, has directed inquiries toward the Food and Drug Administration (FDA). His concern? Why the FDA didn’t scrutinize Elon Musk’s Neuralink before greenlighting human trials for its brain implants.

An exposé by Reuters unearthed FDA inspectors’ findings from last June, shedding light on discrepancies in record-keeping and quality control during animal experiments at Neuralink. This revelation comes mere weeks after Neuralink’s proclamation of FDA clearance for human trials.

Neuralink’s journey from primate trials to human experimentation is now under the microscope. The company’s brain-chip technology offers a glimmer of hope for paralyzed individuals, empowering them to control computers with their thoughts alone.

Blumenauer’s missive to the FDA, dispatched on Monday, underscores his unease with the FDA’s apparent oversight of longstanding grievances regarding animal testing malpractices dating back to 2019. Reports, including those from Reuters, paint a grim picture of rushed experiments dubbed “hack jobs,” sparking concerns about data integrity and animal welfare.

The FDA, in response to Reuters’ inquiries, assured a direct response to Blumenauer while emphasizing routine post-approval inspections for human trials. Despite Neuralink’s FDA inspection, no infractions deemed detrimental to trial safety were uncovered.

As the dialogue unfolds between regulatory bodies and lawmakers, Neuralink remains tight-lipped amidst the scrutiny. The landscape of brain implants sees other players, like Synchron and Blackrock Neurotech, stepping onto the human experimentation stage, demonstrating promising results akin to Neuralink’s endeavors.

Last week, Neuralink showcased a groundbreaking livestream on Musk’s social platform X, spotlighting the inaugural patient’s mind-controlled prowess in online chess. Noland Arbaugh, paralyzed from the shoulders down due to a diving mishap, shared his thoughts via X, epitomizing the potential of Neuralink’s technology in bridging the chasm between mind and machine.

In a climate rife with skepticism and intrigue, the saga of Neuralink unfolds, intertwining technological ambition with regulatory scrutiny.

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