US regulator rejected human trials for Elon Musk’s brain implant startup Neuralink

The US Food and Drug Administration (FDA) rejected an application by Elon Musk’s company Neuralink to conduct human trials with its medical implants in 2022, Reuters reports.

The publication learnt about the rejection through seven current and former employees at the company, which aims to treat conditions like paralysis and blindness through brain implants.

The FDA outlined “dozens” of issues that Neuralink had to address before it could start human trials.

Its primary concerns related to using a lithium battery in Neuralink implants, the potential of wiring connecting to other areas of the brain, and if the device could be removed without damaging brain tissue.

Since 2019, Musk has said Neuralink could “soon” start human trials on several occasions.

The company has been testing Neuralink implants on monkeys for several years.

In April 2021, it showed off how one of its testing subjects could play Pong with its brain.

Although Neuralink never acknowledged the FDA’s rejection, it is not required to do so because it is not publicly listed.

Musk recently said Neuralink would secure FDA human-trial approval by the US Spring (South African autumn).

However, three employees who spoke to Reuters were doubtful about that timeline.

Numerous experts in FDA device approvals told the publication that the FDA’s rejection also signalled substantial safety concerns over Neuralink.

About two-thirds of all human-trial applications submitted to the FDA in the past three years were approved after the first pass.

But it was not clear how many, if any, of these trials involved sophisticated medical technology that interacted with the most complex human organ.

Many approved human trials were likely for more conventional product testing — like new oral drugs or skin cosmetics.

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US regulator rejected human trials for Elon Musk’s brain implant startup Neuralink