Brain implant company Neuralink says it has U.S. approval to begin trials in people

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Elon Musk’s company made the announcement on Twitter Thursday evening but has provided no details about a potential study, which was not listed on the U.S. government database of clinical trials

Elon Musk’s brain implant company Neuralink says it’s gotten permission from U.S. regulators to begin testing its device in people.

Officials with the Food and Drug Administration wouldn’t confirm or deny whether the agency granted the approval, but press officer Carly Kempler said in an e-mail that the FDA “acknowledges and understands” that Musk’s company made the announcement. Earlier this week, for example, researchers in Switzerland published research in the journal Nature describing an implant that restores communication between the brain and spinal cord to help a man with paralysis to stand and walk naturally. There are more than 30 brain or spine computer interface trials under way, according to clinicaltrials.gov.

The device is about the size of a large coin and is designed to be implanted in the skull, with ultrathin wires going directly into the brain. Musk has said the first two applications in people would be to attempt to restore vision and try to help people with little or no ability to operate their muscles rapidly use digital devices. He also said he envisions that signals from the brain could be bridged to Neuralink devices in the spinal cord for someone with a broken neck.

 

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