FDA Approves Neuralink's Brain-computer Tests

Neuralink

Elon Musk predicted FDA approval and was only a month off. The FDA approved Neuralink's application for human trials on Thursday. This happened after the FDA reportedly denied Neuralink in March. The Link prototype brain-computer interface (BCI) is ready for testing.

Neuralink started in 2016 to make BCIs for medical purposes like rehab after a stroke or SCI and controlling neural prosthetics. Elon Musk said in 2020 that Neuralink could even make memories downloadable into robots. BCIs measure your brain's electrical impulses using tiny electrodes and turn them into computer language. The FDA needs companies to test the safety of BCI surgery before commercial use.

The FDA said no to Neuralink's plans to test on humans because animals keep dying with the implant. Reuters got documents that show 1,500 animals died since 2018 while making Neuralink. USDA's inspector is investigating.

The FDA was hesitant about the interface for humans. They were worried about the battery and tiny wires moving in the brain. They also had questions about how to safely remove the device without damaging brain tissue. Neuralink employees told Reuters about these concerns in March.

Neuralink got permission from the FDA to do research, but they're not asking for volunteers yet. The Neuralink team worked hard with the FDA to get this first step done. They hope their technology can help many people in the future. They tweeted on Thursday that they're not accepting people for their study yet.

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