Neuralink Corp. announced it has received Breakthrough Device designation from the FDA for its Blindsight brain-computer interface (BCI) device.
Let’s start with Neuralink.
Launched in 2016, the Fremont, California-based private neurotechnology company was most notably founded by Elon Musk (along with a team of seven scientists and engineers).
- Its focus: Developing non-invasive, brain-computer interfaces (BCIs) capable of “interfacing with every aspect of the human brain,” including enabling people with paraplegia to regain movement and restore vision for the blind.
And how does its technology work, exactly?
Neuralink’s technology is designed to record and decode neural signals, then transmit information back to the brain via electrical stimulation.
About the implant: A surgical robot is used to implant the coin-sized brain chip (called “the Link”) under a person’s skull, which then receives information via neural threads that disperse into various areas of the brain that are responsible for motor skill control.
- Specifically: The implant records neural activity through “1,024 electrodes distributed across 64 neural threads,” which Neuralink notes are “so fine that they can't be inserted by the human hand.”
And a special note about that robot: Its head is designed with the optics and sensors of five camera systems as well as the optics for an optical coherence tomography (OCT) system, according to the company.
And the company’s first product?
Interestingly enough, it’s not the Blindsight implant.
Neuralink developed a wireless brain chip—dubbed the “N1 implant”—with a first indication aimed at restoring digital autonomy to people with “quadriplegia due to spinal cord injury (SCI) or amyotrophic lateral sclerosis (ALS).” (This functionality is dubbed “Telepathy” by the company.)
What progress has been made on it?
This chip was surgically implanted in the skull of the first human patient as part of a human testing phase, Musk announced earlier this year, followed by the second patient.
- See a March 2024 video of that first patient’s progress, posted by Neuralink.
- Also: Learn about the investigation surrounding reports of monkeys being used as testing subjects of this implant—which Neuralink denies.
Its intended capabilities: Among several applications, the chip is designed to restore motor functionality within people, enabling BCI that gives people control of their phones or computers “just by thinking,” according to reports.
So how is Blindsight different from Telepathy?
While Telepathy is intended to enable users to perform activities (such as playing chess or video games), Blindsight is designed to target restoring vision—including in patients “who have lost both eyes and their optic nerve,” Musk has claimed.
He also noted: “Provided the visual cortex is intact, it will even enable those who have been blind from birth to see for the first time.”
Could this really cure blindness?
As much as we’d like to say yes … not likely.
“It is extremely premature to say that such a device could enable blind people to see,” reports have noted.
Further, those who are blind from birth would “not have developed the biological capacity for seeing through their eyes.”
- In fact: More realistic vision expectations may be along the lines of a bionic eye under clinical investigation in retinitis pigmentosa (RP) patients.
Mmm. But the FDA seems to think Neuralink is on to something …
That’s true! BDD is intended to expedite the development, assessment, and review process of certain medical devices for premarket approval, 510(k) clearance, or De Novo marketing authorization.
With this designation: Neuralink is now eligible to receive FDA feedback on their device development via several options, as well as prioritized review for future regulatory submissions of the device.
So is there any clinical data available on Blindsight yet?
As far as we know … no.
The only ongoing first-in-human (FIH) trial Neuralink is conducting is the Precise Robotically IMplanted Brain-Computer InterfacE (PRIME) Study (NCT06429735) which involves those two patients (mentioned earlier)—and a third, according to Clinical Trials—who were implanted using Telepathy.
Neuralink did not immediately return Glance’s request for comment regarding any planned explanations of Blindsight.