A U.S. lawmaker involved in health policy has asked the Food and Drug Administration why it did not inspect Elon Musk’s Neuralink before allowing the brain implant company to test its device in humans.
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The 29-year-old patient who was paralyzed below the shoulder after a diving accident, played chess on his laptop and moved the cursor using the Neuralink device.
Agency inspectors found problems with record keeping and quality controls for animal experiments at Elon Musk’s Neuralink, less than a month after the startup said it was cleared to test its brain implants in humans, according to an agency report reviewed by Reuters.
The first human patient implanted with a brain-chip from Neuralink appears to have fully recovered and is able to control a computer mouse using their thoughts, the startup’s founder Elon Musk said late on Monday.
The first human patient has received an implant from brain-chip startup Neuralink on Sunday and is recovering well, the company’s billionaire founder Elon Musk said.
Four U.S. lawmakers have asked the Securities and Exchange Commission to investigate whether Elon Musk committed securities fraud by allegedly misleading investors about the safety of a brain implant being developed by the billionaire’s firm Neuralink, according to a letter to the regulator.
The study will use a robot to surgically place a brain-computer interface (BCI) implant in a region of the brain that controls the intention to move, Neuralink said, adding that its initial goal is to enable people to control a computer cursor or keyboard using their thoughts alone.
Officials with the Department of Agriculture (USDA) conducted a “focused” inspection in response to a complaint about the company’s handling of animal experiments.
The FDA nod “represents an important first step that will one day allow our technology to help many people,” Neuralink said in a tweet. It did not elaborate on the aims of the study, saying only that it was not recruiting yet and more details would be available soon.
The membership of the panel at Musk’s company, Neuralink, raises questions about potential violations of conflict-of-interest regulations aimed at protecting research integrity, a dozen animal-research and bioethics experts told Reuters. Neuralink is conducting animal experiments as it seeks regulatory approval for human trials of a brain chip intended to help paralyzed people type with their minds, among other ambitious goals.
