In December 2022, founder Elon Musk gave an update on his other, different company, the brain implant startup Neuralink. In 2020, the company said it was close to starting clinical trials of the implants, but a December update suggested that was still six months away. This time, it seems the company is right, as it were now claims that the Food and Drug Administration (FDA) gave their approval for the start of human trials.
Neuralink is not yet ready to start recruiting test subjects, and there are no details on what the trials will include. A search of the ClinicalTrials.gov database for “Neuralink” also turned up nothing. Often, initial trials are small and focused entirely on safety rather than effectiveness. Given that Neuralink is developing brain implants and a surgical robot to do the implantation, there is a lot of testing required.
It is likely that it will focus primarily on implants, since some implants have already been tested on humans, while an equivalent surgical robot has not.
The news is undoubtedly a relief for the company’s staff and its owner Musk, because Neuralink has had many negative interactions with federal regulators of late. This is a bad sign if having an early bid to start clinical trials rejected by the FDA is the least of the company’s problems. The company has also been accused of abusing animals in its research and violating transport rules by shipping implants contaminated with monkey tissue and pathogens.
Usually, when the FDA rejects an application for clinical trials, it is prepared to communicate in detail why it finds the plan for the trials to be inadequate. It is a positive sign for Neuralink that the company was able to respond to the concerns of federal regulators in a relatively short time.
