The US government reportedly denied Elon Musk’s business Neuralink’s intentions to test Brain chips on humans that could ‘help the blind see,’ citing major safety concerns.
Musk had stated that his BCI business, Neuralink, would begin human trials in November of this year.
He shared a video exhibiting the Neuralink’s BCI, or brain-computer interface. In the video, Pager, a nine-year-old monkey with a Neuralink chip implanted in his brain, is taught to play Pong using a joystick.
The joystick was unplugged when the monkey learned the patterns, and his brainwaves were linked to the game, allowing him to play it.
The film received extensive media coverage, with tech pundits suggesting that it would revolutionize medicine and forever alter how humans interacted with technology.
According to a new Reuters article, Musk’s Neuralink implants will be less widely available and adopted than Musk would have liked since US regulators denied Musk’s attempt to test brain chips on humans, citing safety concerns.
Despite being denied by US health officials, Elon Musk has predicted that Neuralink will soon begin human testing of a revolutionary brain implant to treat chronic ailments such as paralysis and blindness on at least four consecutive times.
The rejection of Neuralink by the US Food and Drug Administration (FDA) was previously unknown to the media.
According to Reuters, Musk and Neuralink must overcome dozens of difficulties before beginning human testing, a critical step toward final product approval.
The FDA’s primary safety concerns included the device’s lithium battery, the likelihood of the implant’s small cables migrating to other regions of the brain, and if and how the device could be withdrawn without causing injury to brain tissue. Even as recently as November 2022, Musk was rejected.
During the hour-long protest in November, Musk indicated that the business had submitted “most of our files” to the FDA, but he did not name any formal applications. During the presentation, Neuralink executives erroneously claimed that the FDA had asked them a few safety questions as part of an ongoing and open discussion.
Musk previously stated that Neuralink would receive FDA approval and clearance for human testing by November 30th, assuming the FDA provides them the necessary clearances.
According to the report, Neuralink is still working through the FDA’s objections nearly a year after being denied human trials. Three employees voiced concern that the company could remedy the issues quickly, especially given the deadline.