Media: Neuralink denied permission to test brain implants in humans

American regulators declined to grant Neuralink permission to test brain implants in humans. Reuters reports.

According to the agency, in early 2022, Elon Musk’s startup filed an application with the U.S. Food and Drug Administration (FDA). However, the agency judged the current risks too high.

In its rationale for the denial, the FDA enumerated dozens of issues that could arise during the trials. The greatest concerns were:

• the implant’s lithium battery;
• the risk of tiny wires migrating to other parts of the brain;
• the possibility of removing the device without damaging brain tissue.

Former and current Neuralink employees told the agency that a year after the denial the company had not solved the challenges. Nevertheless, Musk promised that in spring 2023 the company would obtain the necessary approvals.

Neuralink’s official representatives did not respond to media inquiries. The FDA declined to comment, citing laws protecting commercial information.

Neuralink was founded in 2016. The company is developing neural implants that, according to Musk, could help treat conditions such as paralysis and blindness.

In April 2021, the billionaire demonstrated a monkey with an implanted chip in the brain cortex playing ping-pong by thought alone.

However, in 2022 the company faced a wave of criticism. Animal rights activists accused Neuralink of causing “great suffering” to the test monkeys. Later Reuters reported that the United States Department of Agriculture’s Inspector General launched an investigation into the matter.

Earlier, Neuralink opened a vacancy for the director of clinical trials.

In November, Science, the publication owned by Neuralink co-founder Max Hodak, presented a neural interface for treating blindness.

Earlier, the American startup Synchron launched clinical trials of the first commercial brain implant.