Many Deficiencies in Musk Neuralink Brain Chip: FDA

FDA has rejected a request from Elon Musk’s Neuralink for permission to conduct human trials of a brain implant that Musk has said will ultimately make the paralyzed walk and the blind see. Reuters reports that the agency listed dozens of deficiencies that must be resolved before any approval could be given. The rejection has not been made public and was disclosed to the news service by multiple anonymous company sources.

The sources said the agency’s primary safety concerns involved 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 device could be removed without damaging brain tissue.

Musk, other company officials, and FDA officials all declined Reuters’ requests for comment on the lengthy investigative report.

“Such FDA rejections do not mean a company will ultimately fail to gain the agency’s human-testing approval,” the story says. “But the agency’s pushback signals substantial concerns, according to more than a dozen experts in FDA device approval processes.”

The experts Reuters interviewed said the rejection raises the stakes and the difficulty of the company’s subsequent requests for trial approval. They noted that FDA has said it has approved about two-thirds of all human trial applications for devices on the first attempt over the past three years. The total rose to 85% of all requests after a second review. Firms often give up after three attempts to resolve agency concerns rather than invest more time and money in expensive research, the experts said. Companies that do secure human testing approval typically conduct at least two rounds of trials before applying for FDA approval to commercially market a device, they said.

The report says that more than a dozen current and former Neuralink employees said the regulatory struggles stem largely from a company culture of setting goals for breakthroughs on extremely ambitious timelines and viewing regulators as obstacles to innovation.

Neuralink officials have publicly vowed to address any FDA concerns, Reuters reports. Musk made headlines last year when he said he was already so confident in the device’s safety that he would be willing to implant it in his children.

“Musk’s public claims and well-known impatience pose a critical test for FDA in balancing demands for speedy review with the diligence required to ensure safety and efficacy, said Kip Ludwig, former program director for neural engineering at the National Institutes of Health,” Reuters says. “FDA in recent years has faced pressure from Congress to accelerate reviews but also criticism over controversial approvals, such as the 2021 authorization of an Alzheimer’s treatment without conclusive proof of efficacy.”