Elon Musk's Neuralink Receives FDA Approval For Second Human Brain Chip Implant: Report

Elon Musk’s Neuralink Corp has reportedly received approval from the U.S. Food and Drug Administration (FDA) to proceed with implanting its brain chip in a second participant.

The decision follows adjustments made to address issues encountered in the first human trial.

The improvements involve placing the device’s delicate wires deeper into the brain, reported The Wall Street Journal, which cited a person familiar with the company and a document.

As Neuralink gears up for its second implant, Noland Arbaugh, the first participant, has shared his experiences and the profound impact of the device on his life.

After his surgery in January, Arbaugh, a quadriplegic, managed to control a computer cursor using only his thoughts, which allowed him to communicate and engage in activities he had been unable to perform since his accident eight years ago.

However, a month later, the device’s performance deteriorated as most of the implanted threads dislodged, hindering the signal transmission needed for cursor movement.

The malfunctioning of tiny wires in the brain implant has been known for years, even before the company acknowledged it.

“I was on such a high and then to be brought down that low. It was very, very hard,” Arbaugh recalled in an interview. “I cried.”

The N1 implant, a small device containing electronics and a battery, uses 64 ultra-thin threads inserted into the brain’s motor cortex to relay neural signals. 

Although about 15% of these threads remain functional in Arbaugh’s brain, subsequent software updates have helped restore many of the device’s capabilities, which he has demonstrated during live streams.

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To prevent similar issues, Neuralink proposed embedding the threads deeper into the brain, a plan approved by the FDA, the report noted.

The company aims to implant the second participant in June and has more than 1,000 potential candidates, with fewer than 100 qualifying for the study. 

Despite this, Neuralink is still accepting applications, as confirmed by Elon Musk on X (formerly Twitter).

Neuralink plans to implant its device in 10 individuals this year, striving for a diverse participant pool. However, the current applicant demographics skew heavily towards white males. 

The company also intends to seek regulatory approval in Canada and the U.K., with patient registries soon opening in both countries.

Arbaugh’s initial disappointment over the device’s malfunction was tempered by the realization that his experience would benefit future recipients. 

Neuralink’s engineers have since enhanced his device by refining how it decodes brain signals, focusing on stronger neural signals and improving the recording algorithm to be more sensitive to neural population signals.

“It makes me very, very hopeful for the future,” Arbaugh said, as per the report. “It seems like we’ve learned a lot and it seems like things are going in the right direction.”

Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

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