In December 2022, founder Elon Musk gave an update on his other, different company, the brain-implant startup Neuralink. As far back as 2020, the company had said it was about to start clinical trials on the implants, but the December update suggested it would be another six months. This time, it seems the company was right claims now that the Food and Drug Administration (FDA) has given approval for the start of human testing.
Neuralink is not yet ready to recruit subjects and there are no details about what the trials will entail. Searching the ClinicalTrials.gov database for “Neuralink” turns up nothing either. Typically, initial studies are small and focused entirely on safety rather than effectiveness. Since Neuralink is developing brain implants as well as a surgical robot to do the implanting, there will be a lot of testing to do.
It is likely that these will focus on the implants first, as other implants have already been tested in humans, while a similar surgical robot has not.
The news is no doubt a relief to both the company’s staff and owner Musk, as Neuralink has had several negative interactions with federal regulators recently. It’s a bad sign if a previous bid to start clinical trials that was rejected by the FDA was the least of the company’s problems. The company has also been accused of mistreating its lab animals and violating transportation regulations by shipping implants contaminated with monkey tissue and pathogens.
When the FDA denies a clinical trial application, it is usually willing to communicate in detail why it found the trial plan inadequate. It is a positive sign for Neuralink that the company was able to address the concerns of federal regulators in a relatively short period of time.
