Neuralink has announced that the U.S. Food and Drug Administration (FDA) has approved its first-in-human clinical trial.
“We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study! This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people,” said Neuralink in a tweet. “Recruitment is not yet open for our clinical trial. We’ll announce more information on this soon!”
Neuralink was founded by Elon Musk, Benjamin Rapaport, Dongjin Seo, Max Hodak, Paul Merolla, Philip Sabes, Tim Gardner, Timothy Hanson, and Vanessa Tolosa. Hodak no longer works at the company.
Musk strongly believes that brain implants could eventually cure a wide range of conditions like obesity, autism, depression, and schizophrenia. And Musk went as far as claiming that he would even consider implanting this technology into his children. Neuralink first pursued FDA approval in early 2022 and the agency rejected the application at the time.
The FDA cited several concerns such as the use of lithium batteries in the device and the potential for the implant’s wiring to migrate within the brain. Plus there have been concerns about safely extracting the device without damaging brain tissues.
This past May, U.S. lawmakers pushed regulators to investigate the makeup of the panel who were overseeing animal testing at the company. The Department of Transportation is also investigating whether Neuralink has illegally transported dangerous pathogens on chips that were removed from monkey brains without proper containment processes. And the U.S. Department of Agriculture’s Office of Inspector General is investigating the company for potential animal-welfare violations.
Back in July 2020, Musk revealed that Neuralink obtained an FDA breakthrough device designation that allows limited human testing under the FDA guidelines for medical devices.
In April 2021, Neuralink demonstrated a monkey playing Pong using the Neuralink implant. This implant showcased progress in making the implant wireless and increasing the number of implanted electrodes:
Neuralink’s Link brain implant is intended to eventually help patients with severe paralysis and/or other neurological conditions, enabling them to control external devices and communicate thoughts. Plus Neuralink is also developing ocular implant technology for restoring human vision and spinal cord implants – which would be able to help restore body movements.
