Neuralink, FDA Knew About Neurochip Wire Issue All Along

Neuralink went ahead with its human trials, fully knowing that the neurochip’s wires retracted, according to Reuters.

• Initially successful, quadriplegic patient Noland Arbaugh experienced neurochip malfunction when its tiny threads retracted, affecting signal measurement.
• Both the FDA and Neuralink were aware of the wire issue.

Neuralink knew for years that the tiny wires of its neurochip could potentially retract and yet still went ahead with its first human trial.

Earlier this year, the brain-computer interface (BCI) company started its human trials after it received the Food and Drugs Administration’s (FDA) long-awaited approval. 29-year-old Noland Arbaugh, a quadriplegic patient, then received the N1 Link brain implant. Initially, the surgery was a success with the patient playing several video games and completing tasks. But it wasn’t long before the other shoe dropped.

Last week, Neuralink disclosed that Arbaugh’s neurochip had malfunctioned, as the tiny threads connecting it to precise areas of the brain had retracted. This affected the implant’s ability to measure brain signals accurately. To remedy this, the team modified the recording algorithm.

As with any medtech or pharmaceutical innovation, we need to have several rounds of trials to iron out all the kinks. Failures and setbacks are expected, needed even to collect the data and ensure that the product is as safe as possible once it goes out to the general public. In certain cases, the patients even sign waivers, acknowledging the risk they are taking.

But here’s the plot twist. According to five people familiar with the matter who anonymously spoke with Reuters, Neuralink has known about this specific issue in its neurochip for years. In fact, they have known about this since the animal testing phase. Despite this knowledge, the company deemed the risk low enough to proceed without redesigning the wires.

Reportedly, redesigning the neurochip to avoid the retraction of the threads is not a valid option. It would run the risk of brain tissue damage during the anchoring or removal of the device.

The FDA had access to the animal testing results, as it cited the company for issues related to their animal lab practices. So, according to one of the sources, the agency was well aware of the potential issue with the wires. The FDA even rejected the BCI company’s first application for human trials in 2022 over safety risks. The regulatory agency neither denied nor admitted to this. Instead, it told Reuters, “It would continue to monitor the safety of patients enrolled in Neuralink’s study.”

Speaking of Neuralink’s animal testing, some of its pigs who had the neurochip developed granulomas, a type of inflammation that forms as a reaction to infections, inflammation, irritants or foreign objects.. The researchers were worried that the threads were behind the issue. Reportedly, after a long investigation, the company could not determine the cause, but ultimately concluded that neither the device nor its threads were responsible.

It’s one thing for new issues to pop up during human testing, but it’s a whole other thing to have gone through with the human trial knowing that these potential severe issues exist. That’s gross negligence; they recklessly disregarded the safety and well-being of their patient.

There was a conscious decision to move forward, putting Arbaugh at undue risk.

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