U.S. regulators have refused to grant Neuralink permission to test brain implants on humans. Writes about it Reuters.
Elon Musk’s startup filed an application with the US Food and Drug Administration (FDA) in early 2022, according to the agency. However, the agency considered the current risks too high.
In justifying the refusal, the FDA listed dozens of problems that could arise during the trial. The biggest concerns were:
- lithium battery implant;
- the likelihood of tiny wires migrating to other parts of the brain;
- the possibility of removing the device without damaging the tissues of the organ.
Former and current employees of Neuralink told the agency that a year after the refusal, the company did not solve the tasks. Despite this, Musk promised that the company will receive the necessary approvals in the spring of 2023.
Neuralink officials did not respond to media inquiries. The FDA declined to comment, citing commercial privacy laws.
Neuralink was founded in 2016. The company is developing neuroimplants that Musk says will help cure diseases like paralysis and blindness.
In April 2021, the billionaire showed a monkey with a chip implanted in the cerebral cortex, which plays ping-pong with the power of thought.
However, in 2022, the company faced a wave of criticism. Animal rights activists have accused Neuralink of causing “great suffering” to experimental monkeys. Reuters later reported that the USDA Inspector General launched an investigation into the matter.
Recall that in January, Neuralink opened a vacancy for the director of clinical trials.
In November, Science, owned by Neuralink co-founder Max Hodak, unveiled a neural interface for treating blindness.
Earlier, the American startup Synchron launched clinical trials of the first commercial brain implant.
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