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Neuralink can now study its brain implant in humans after securing a go-ahead from the Food and Drug Administration. It’s a critical turning point for the Elon Musk-led company — but the startup, however closely watched, is playing catch-up compared to its peers in the neurotechnology field.

“In terms of first in human, Neuralink is almost two decades behind,” said JoJo Platt, a neurotech strategist.


Neuralink announced the long-awaited FDA nod on Thursday evening. FDA spokesperson Carly Kemper told STAT in an email that the agency “acknowledges and understands that Neuralink has announced that its investigational device exemption (IDE) for its implant/R1 robot was approved by the FDA and that it may now begin conducting human clinical trials for its device.”

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