Neuralink Gets FDA Approval for Second Brain Implant Patient

Neuralink has received approval from the FDA to implant its brain chip into another patient.

The Wall Street Journal reports that the Elon Musk-owned company received approval after it promised to address the issues it encountered with the first implementation. The problem, according to the biotechnology company, stemmed from an electrode issue that limited the device’s functionality.

The first patient, Noland Arbaugh, encountered issues after the “threads” in the brain implant had come loose, rendering it useless when it came to translating the electrical signals that turned his thoughts into actions. The threads came loose after only a month of implantation.

However, Arbaugh told Good Morning America that he didn’t regret getting the Neuralink implant and feared the malfunction would require the implant’s removal.

“I can control a computer just like anyone else can, which is not something I was able to do beforehand,” he said. “It was very, very hard to give up all of the amazing things that I was able to do.”

Arbaugh became paralyzed from the shoulders down after jumping into a manmade lake. Neuralink was able to modify the technology to improve the connection, according to co-founder DJ Seo, and Arbaugh still has the implant to this day. He has also subsequently demonstrated that it still works effectively on livestreams since the malfunction.

According to the WSJ report, a person familiar with Neuralink explained that the company planned to fix the problem in the future by embedding some of the wires from the device deeper into the brain. Neuralink’s second patient will likely have the device implanted in June, and the company expects to have 10 total patients get the devices by the end of the year.

In March, Neuralink was under FDA investigation thanks to concerns raised by U.S. representative Earl Blumenauer about the government agency’s alleged failure to properly vet the company prior to greenlighting the first implantation.

FDA inspectors’ findings from June of last year were uncovered by Reuters in an exposé that revealed inconsistencies in Neuralink’s record-keeping and quality control during animal trials. Only a few weeks had passed since Neuralink announced that it had FDA authorization for human testing.

In response to questions from Reuters, the FDA stressed the importance of regular post-approval inspections for human trials while promising Blumenauer a direct answer. The FDA inspected Neuralink but found no violations that would have jeopardized trial safety.

In the face of intense scrutiny, Neuralink remained mum as the conversation between lawmakers and regulatory authorities continued. Other firms in the brain implant space, such as Synchron and Blackrock Neurotech, are entering the human testing arena and showing encouraging outcomes similar to Neuralink’s pursuits.