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Elon Musk's Neuralink gets FDA approval for study of brain implants in humans

   By [14]Akriti Sharma (BUTTON)
   May 26, 202312:29 AM UTCUpdated ago
   Illustration shows Neuralink logo and Elon Musk photo
   Neuralink logo and Elon Musk photo are seen in this illustration taken,
   December 19, 2022. REUTERS/Dado Ruvic/Illustration/File Photo/File
   Photo
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   May 25 (Reuters) - Elon Musk's brain-implant company Neuralink on
   Thursday said it had received a green light from the U.S. Food and Drug
   Administration (FDA) to kickstart its first-in-human clinical study, a
   critical milestone after earlier struggles to gain approval.

   On at least four occasions since 2019, Musk has predicted that his
   medical device company would begin human trials for a brain implant to
   treat severe conditions such as paralysis and blindness.

   Yet the company, founded in 2016, only sought FDA approval in early
   2022 - and the agency rejected the application, seven current and
   former employees [15]told Reuters in March.

   The FDA had pointed out several concerns to Neuralink that needed to be
   addressed before sanctioning human trials, according to the employees.
   Major issues involved the lithium battery of the device, the
   possibility of the implant's wires migrating within the brain, and the
   challenge of safely extracting the device without damaging brain
   tissue.

   Thursday's FDA approval comes as U.S. lawmakers are urging regulators
   to [16]investigate whether the make-up of a panel overseeing animal
   testing at Neuralink contributed to botched and rushed experiments.

   Neuralink has already been the subject of federal probes.

   Reuters reported on Dec. 5 that the USDA's Inspector General was
   investigating, at the request of a federal prosecutor, potential
   violations of the Animal Welfare Act, which governs how researchers
   treat and test certain types of animals.

   The probe has also been looking at the USDA's oversight of Neuralink.

   In a tweet on Thursday, Neuralink said it is not yet open for a
   clinical trial.

   "This is the result of incredible work by the Neuralink team in close
   collaboration with the FDA and represents an important first step that
   will one day allow our technology to help many people," Neuralink said
   in a tweet on Thursday.
   loading

   Over the years, Musk has publicly outlined an ambitious plan for
   Neuralink. He made headlines late last year when he said he was already
   so confident in the devices’ safety that he would be willing to implant
   them in his own children.

   Musk envisions both disabled and healthy individuals swiftly getting
   surgical implants at local centers. These devices aim to cure a range
   of conditions from obesity, autism, depression, schizophrenia, to
   enabling web browsing and telepathy.

   The FDA did not immediately respond to a Reuters request for comment.
   Reporting by Akriti Sharma in Bengaluru; Editing by Anil D'Silva and
   Lincoln Feast
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   Our Standards: [17]The Thomson Reuters Trust Principles.

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