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The FDA approval "represents an important first step that will one day allow our technology to help many people," Neuralink said in a tweet on Thursday, without disclosing details of the planned ...
Neuralink received FDA approval for human clinical trials in May 2023. [90] The FDA had rejected a 2022 application to pursue human clinical trials, citing "major safety concerns involving the device's lithium battery; the potential for the implant's tiny wires to migrate to other areas of the brain; and questions over whether and how the ...
Neuralink has completed the first implant in a human brain after receiving FDA approval for a human study last year, according to Musk.
Neuralink did not immediately respond to a request seeking details about when it expects the Blindsight device to move into human trials. The FDA also did not immediately respond to a request for ...
Neuralink, the neurotech startup co-founded by Elon Musk, announced Thursday it has received approval from the Food and Drug Administration to conduct its first in-human clinical study.
Blindsight is an experimental medical device developed by Neuralink. [ 1 ] [ 2 ] It has received Breakthrough Device Designation from the US Food and Drugs Administration (FDA) . [ 3 ] [ 4 ]
The agency also said it routinely carries out inspections after a human trial is approved. When it inspected Neuralink, the FDA said it did not find violations that would undermine the safety of ...
Neuralink did not respond to a request for comment about whether it had fixed any of the problems identified by the FDA. The company has said it goes above and beyond existing regulations in its ...