Musk's Neuralink Receives FDA Clearance for First-in-Human Clinical Trial
- May, 27, 2023 - 12:04
- Science news
TEHRAN (Tasnim) – Elon Musk's brain-implant startup, Neuralink, obtained clearance from the US Food and Drug Administration (FDA) for its initial human clinical trial, marking a significant milestone.
This approval comes as the company faces investigations in the United States regarding its handling of animal experiments. Neuralink expressed the importance of this first step in a tweet, stating, "It will one day allow our technology to help many people."
The company, however, did not disclose specific details about the planned study, mentioning that recruitment for the trial has not yet begun and promising more information in the near future.
The FDA confirmed in a statement that it has granted clearance to Neuralink for the use of its brain implant and surgical robot in patient trials but refrained from providing further particulars.
This milestone achievement for Neuralink arrives amidst federal scrutiny following reports by Reuters about the company's animal experiments.
According to Neuralink employees, rushed surgeries on monkeys, pigs, and sheep, driven by Musk's pressure to obtain FDA approval, led to unnecessary animal deaths. Sources revealed that the animal experiments generated data intended to support the company's application for human trials.
One incident in 2021 involved the implantation of incorrectly sized devices in 25 out of 60 pigs. All the pigs were subsequently euthanized, a mistake that employees asserted could have been easily prevented with better preparation.
In May, US lawmakers called for regulators to investigate potential financial conflicts within the panel overseeing animal testing at Neuralink, as reported by Reuters.
Additionally, the Department of Transportation initiated a separate inquiry into whether Neuralink unlawfully transported hazardous pathogens on chips removed from monkey brains without adequate containment measures.
Neuralink is also under investigation by the US Department of Agriculture's Office of Inspector General for possible violations of animal welfare. This investigation focuses on the USDA's oversight of Neuralink. Concerns raised by employees about rushed experiments and the resulting suffering and deaths of pigs, sheep, and monkeys prompted the probe.
According to FDA records and a Neuralink employee, as of a few weeks ago, the FDA had not conducted an inspection of Neuralink's laboratory practices. Victor Krauthamer, an adjunct biomedical engineering professor and former FDA official, expressed his belief that the FDA should have inspected Neuralink given the concerns surrounding its animal experiments. He emphasized the importance of reliable animal testing to ensure the validity of human trial approvals.
Earlier reports indicated that Neuralink had initially aimed to implant its device in ten patients. However, due to safety concerns raised by the FDA, the company engaged in negotiations with the agency to reduce the number of patients. The exact number of patients approved by the FDA remains unknown.
Musk envisions brain implants as a potential cure for various conditions such as obesity, autism, depression, and schizophrenia, while also enabling web browsing and telepathy. He attracted attention when he expressed his confidence in the safety of the devices, stating that he would be willing to have them implanted in his own children.
Despite Musk's previous predictions since 2019 about commencing human trials, Neuralink only sought FDA approval in early 2022, and the application was rejected.
The FDA had highlighted several safety concerns to Neuralink that needed to be addressed before approving human trials. These concerns included the lithium battery of the device, the potential migration of the implant's wires within the brain, and the safe extraction of the device without damaging brain tissue.