Neuralink, the brain-implant startup founded by Elon Musk, has received approval from the U.S. Food and Drug Administration (FDA) to commence its first human clinical study, as announced by the agency. The company’s goal is to develop a device that enables individuals to control computer interfaces using their brains, with the potential to restore vision and assist those with severe disabilities in movement and communication by decoding brain activity.
Neuralink plans to establish clinics where surgical robots will implant their proprietary electrodes, designed for brain-signal recording, into patients’ brains. This milestone approval comes after extensive collaboration between Neuralink’s team and the FDA, marking a significant step forward towards making their technology beneficial to many individuals.
Although recruitment for the trial has not yet begun, Neuralink intends to provide further information in the near future. Elon Musk had previously expressed the company’s intention to seek FDA approval for human testing, with initial estimates suggesting approval could be obtained as early as 2020.
Neuralink has conducted extensive testing of its implant technology on primates over the years. In April 2021, the company released a video showcasing a monkey implanted with two Neuralink devices, successfully playing the video game Pong solely using its brain.
Safety and long-term effectiveness in clinical testing are crucial prerequisites before introducing a brain-computer interface to patients, as emphasised by neurotechnology experts. Addressing concerns raised by the FDA regarding device overheating and potential chemical seepage into the brain from the implant has been a priority for Neuralink. The company has acknowledged incidents of suspected device-associated infections in monkeys, leading to their euthanization in February 2022. Neuralink has since developed new surgical protocols and considers device-associated infections as inherent risks for any medical device implanted through the skin.
Neuralink’s FDA approval for human clinical study marks a significant achievement in their journey towards developing groundbreaking brain-implant technology. It paves the way for potential advancements in human-machine interfaces and holds promise for individuals seeking innovative solutions to restore or enhance their cognitive abilities.
