World Death knell for Neuralink? US regulators rejected Elon Musk’s bid to test brain chips on humans Elon Musk had announced that his BCI company, Neuralink would start human trials by November this year. However, the US FDA had rejected Neuralink's bid for human trials long before Musk made that claim, citing some serious safety issues. FP Staff March 02, 2023 19:14:20 IST Elon Musk had announced that his BCI company, Neuralink would start human trials by November this year.
However, the US FDA had rejected Neuralink's bid for human trials long before Musk made that claim, citing some serious safety issues. When Elon Musk demonstrated the BCI or brain-computer interface that his neural computing startup, Neuralink was working on, it got a lot of press. Several tech pundits and Musk fans claimed that it would revolutionise medicine, that it would change how humans interacted with computers forever.
It was considered that Neuralink specifically, not BCIs in general, would be the next big thing. The footage shows a nine-year-old macaque called Pager with a Neuralink chip inserted in his brain. Pager was first taught to play Pong with a a joystick.
After learning the patterns, the joystick was disconnected and the monkey's brainwaves were connected to the game. pic. twitter.
com/YM0n8EjISk — prayingforexits ????☠️ (@mrexits) February 25, 2023 However, a recent Reuters investigation has found that Musk’s Neuralink implants won’t be as widely available and widely adopted as Musk and his supporters would have wanted it to be. Ly According to a special Reuters report, US regulators have repeatedly rejected Musk’s bid to test brain chips on humans, citing safety risks. Rejected on a number of occasions Elon Musk has forecasted that his medical device business, Neuralink, will soon begin human testing of a revolutionary brain implant to cure chronic diseases like paralysis and blindness at least on four separate occasions.
Also read: What is Neurotechnology and Brain-Computer Interface, the tech that Elon Musk’s Neuralink uses? However, Neuralink had failed to seek permission from the US FDA or Food and Drug Administration (FDA) until early 2022, after which he was rejected, mainly becasue of safety concerns. The refusal had not previously been published. The agency detailed dozens of issues that Musk and Neuralink must resolve before they can begin human testing, a key milestone on the road to final product clearance, say current and former Neuralink employees.
The FDA’s main safety concerns included the device’s lithium battery, the possibility of the implant’s microscopic cables migrating to other regions of the brain, and whether and how the device could be removed without harming brain tissue. During the hour-long demonstration in November, Musk stated that the company had filed “most of our papers” to the FDA, without naming any formal application. Right after the presentation Neuralink executives falsely claimed that the FDA asked them a few questions on safety, in what they said was an ongoing and open discussion.
Race against the clock Musk has already announced that by November 30 this year, Neuralink would get FDA approval and that they should get clearance on human trials anyday now, and it is upto the FDA to grant them the required permissions to do so. Neuralink is still working through the agency’s concerns almost year after they were denied human trials. Three employees expressed scepticism that the business could swiftly resolve the problems, especially given the deadline.
Also read: Elon Musk’s Neuralink startup releases clip of a monkey playing video game called Pong with its brain Such FDA rejections do not necessarily imply that a business will fail to obtain human-testing clearance from the agency. However, according to more than a dozen FDA device-approval procedure specialists, the agency’s pushback indicates serious worries. According to experts speaking to Reuters, the denial increases the stakes and complicates the company’s future requests for trial clearance.
The government tried to help and fund research Although Neuralink made BCIs a buzzword all of a sudden, they are not the first organisation to work on them. There are more than a dozen companies currently that are developing or manufacturing neuromodulation devices, which record or stimulate neural activity in the brain in a market which is worth $6 billion today. As part of its BRAIN programme, the National Institutes of Health (NIH), which promotes and finances medical innovation, wants to assist brain-implant businesses through public-private partnerships (Brain Research through Advancing Innovative Neurotechnologies).
The organisation provides funding to a number of businesses. Aside from grants, it gives access to government specialists who can counsel on how to obtain FDA clearance and market a device. Also read: Elon Musk’s Neuralink: Two neurosurgeons weigh in on the feasibility of Musk’s brain implant and its potential According to BRAIN initiative team head Nick Langhals, the agency sought out to Neuralink to give assistance but was turned down.
“We wouldn’t leave a business like Neuralink off the list,” Langhals said, adding that the company didn’t clarify why it wasn’t interested. According to one individual who witnessed Musk’s remarks and a second source with knowledge of Musk’s opinions on the NIH, Musk warned top Neuralink executives that NIH money would bring unwanted public oversight and bureaucratic hurdles. The incident represents a broader view at Neuralink that the government moves slowly and stifles innovation, according to five current and former workers.
Neuralink could benefit from new federal legislation aimed at expediting FDA evaluations. Among a slew of policy changes, Lawmakers established the “breakthrough” classification for novel devices aimed at severe diseases. According to the FDA, the breakthrough-device programme, among other adjustments, has helped the FDA significantly decrease the overall time businesses spend pursuing agency clearances.
In addition, the government must reply to human-trial applications within 30 days. According to the FDA, more than 100 of the 750 devices presently designated as breakthroughs are neurological. According to the business, Neuralink will receive the label for its brain device in July 2020.
The label, however, does not inherently imply that Neuralink has a viable product. Major safety concerns According to five Neuralink insiders, the FDA’s rejection names dozens of “deficiencies” that the business must resolve before human trials. Some problems were labelled as trivial.
According to six current and former workers, one major FDA worry was that the device’s tiny cables, which contain electrodes, could migrate to other regions of the brain. According to three Neuralink sources, the firm has attempted to resolve the problem by conducting animal experiments on dozens more pigs. Also read: Musk’s Neuralink in trouble for mishandling contaminated devices removed from monkey brains Migrating cables can cause inflammation, impede brain function in crucial regions, and rupture blood vessels.
The cables have the potential to inflict harm. According to specialists in brain technologies, the FDA’s worries about the battery are also possibly severe. Neuralink suggested designing its gadget with an innovative charging system that included lithium batteries that could be refilled remotely.
According to six current and former Neuralink workers, the agency determined that the firm needed to demonstrate in animal tests that the battery was very unlikely to fail. If any gadget component linked to the battery current fails, the current could possibly damage brain tissue. The FDA also questioned whether the BCI could be removed without causing damage to brain tissue.
Officials at Neuralink recognised but downplayed the FDA’s concern in their November presentation. Read all the Latest News , Trending News , Cricket News , Bollywood News , India News and Entertainment News here. Follow us on Facebook , Twitter and Instagram Updated Date: March 02, 2023 19:16:50 IST TAGS: Bci Elon Musk Neuralink Neuralink Human Trials.
