Bangalore, India, March 3, 2023
Introduction:
Elon Musk has projected that his medical device business, Neuralink, will soon begin human trials of a ground-breaking brain implant FDA Rejects Musk’s Bid to Test Brain Chips in Humans to treat untreatable illnesses including paralysis and blindness at least four times since 2019.
Nevertheless, the company, which was established in 2016, didn’t apply for approval from the FDA until early 2022, and the organisation rejected the request, according to some employees of the organisation.
The refusal hasn’t before been disclosed. The decision was communicated to Neuralink along with a long list of difficulties that needed to be resolved before humans testing, a crucial step towards ultimate product approval, according to the staff.
The implant’s lithium battery, the potential for the small wires to spread to other parts of the brain, and the possibility that the device might be withdrawn without harming brain tissue were the three main safety concerns for the agency, according to the employees.
Neuralink is still working through the agency’s issues a year after the rejection. Notwithstanding Musk’s most recent promise that the firm would obtain FDA human-trial approval this spring at a presentation on November 30, a few employees said they were unconvinced the company could rapidly fix the obstacles.
The specifics of Neuralink’s trial application, the FDA’s rejection, or the scope of the agency’s concerns have not been made public. It is not required to divulge such regulatory interactions to investors as it is a private corporation. Musk said, without elaborating, that the business had submitted “most of our paperwork” to the FDA during the lengthy presentation in November, and Neuralink representatives acknowledged that the FDA had questioned the company’s safety during what they described as an ongoing conversation.
Such FDA denials do not necessarily indicate that a business will ultimately be denied the agency’s approval for human testing. More than a dozen specialists in the FDA device-approval procedures, however, believe that the agency’s opposition indicates serious issues.
According to the experts, the company’s following requests for trial permission will be more challenging and at greater risk as a result of the refusal. According to the FDA, during the last three years, it has approved roughly two-thirds of all device submissions for human trials on the first try. After further assessment, that percentage increased to 85% of all requests. Yet, corporations sometimes give up after three efforts to address FDA concerns rather than spending more time and money on pricey research, according to a number of the experts.
Neuralink has regulatory challenges in large part because of its culture of setting breakthrough goals on incredibly aggressive deadlines and considering regulators as hinderances to innovation.
Throughout the years, Musk has outlined a daring vision for Neuralink in public comments: Both healthy and disabled individuals will visit nearby institutions for quick surgical
implantations of gadgets that can do everything from treat obesity, autism, depression, or schizophrenia to allow online browsing and telepathy. According to Musk, these chips would eventually transform people into cyborgs capable of fending off the threat posed by sentient robots equipped with artificial intelligence.
If that sounds like it came from a sci-fi movie, that’s because the notion of a threat from AI has been highly played by the production houses and many scientists have warned us about the possible implications of the rapid rate at which the industry of AI is progressing.
