Health N Tech Transformation
Strategy Institute
Joaquim Cardoso MSc
Chief Research, Editor and Senior Advisor
May 27, 2023
KEY TAKEAWAYS:
- Neuralink, Elon Musk’s brain-computer interface company, claims to have received FDA approval for its first in-human clinical study. This suggests that the company may soon implant its devices in actual humans.
- Elon Musk previously stated that Neuralink was about six months away from its first human trial, and this announcement indicates that the company is keeping its timeline promises.
- The upcoming human trial is significant because it involves attaching a device to a human brain, a milestone that Elon Musk, a prominent figure, will be directly involved in.
- It remains uncertain who will participate in the human trial and their motivations for doing so. It could be individuals with medical needs or those seeking attention by being associated with Elon Musk. Elon Musk himself has expressed his intention to have the device implanted in his own head in the future.
- Neuralink has faced allegations of mistreatment of its monkey test subjects, which the company denies. It is also under investigation for transporting contaminated devices removed from monkeys. These issues raise concerns about the ethical aspects of the company’s practices.
DEEP DIVE
The FDA will apparently let Elon Musk put a computer in a human’s brain
The Verge
By Sean Hollister and Jay Peters
May 25, 2023
Elon Musk’s brain-computer interface company Neuralink says it has received Food and Drug Administration (FDA) approval to launch its first in-human clinical study. If this is true, it means that actual humans could be getting a device from Neuralink implanted in their heads.
The news follows Elon Musk’s November claim that Neuralink was about six months away from its first human trial — which suggests it’s the rare Musk promise that’s actually coming true on time. The announcement of a future human trial isn’t nearly as much of a milestone as the results of that trial. But this isn’t just any trial. This represents Elon Musk, of all people, getting to attach a device to a human brain.
And it makes us wonder: who would sign up for such a thing, and why? Will it be someone who might have an important medical reason or someone who wants to draw the world’s attention at Musk’s side, and is there any chance it’s Elon Musk himself? Musk has claimed he will get the device implanted in his own head at some unspecified time in the future.
Meanwhile, Neuralink has been accused of abusing its monkey test subjects, a claim the company denies, and is under investigation for allegedly transporting contaminated devices removed from monkeys. The FDA rejected an early 2022 Neuralink application for human trials, as reported by Reuters, apparently outlining “dozens of issues” the company needed to address.
Musk’s Neuralink would not be the first to implant a brain-computer interface in a human: Synchron was approved by the FDA to begin US trials in 2021 and announced the first US brain-computer implant last July. This January, it published the results of an earlier study of four human patients in Australia.
If you’re thinking that you, yourself, would like to be part of the Neuralink trial, there’s nothing for you to do for now. Neuralink says that recruitment isn’t open yet and that it will announce more information “soon.”
Originally published at https://www.theverge.com on May 25, 2023.
