Neuralink's Blindsight Receives FDA Breakthrough Device Designation for Restoring Vision in the Blind

Acquired Vision Impairment or Congenital Blindness, have the chance to regain their sight?!

Just moments ago, Musk announced that his company Neuralink'sBrain-Implanted Chip "Blindsight", officially received the FDA (U.S. Food and Drug Administration) "Breakthrough Device Designation."

It is understood that such certification is typically granted under the following circumstances:

Preliminary clinical evidence suggests that this drug/device, compared to existing treatment methods,Demonstrated Substantial Improvement in Clinical Significance。

Once this certification is obtained, Blindsight can acquirePriority Review。

Devices with this certification will receive FDA priority review and enhanced communication with the FDA.
The goal is typically to reduce the approval time to6 months or less, depending on data quality and submission readiness.

△From the FDA Official Website

Moreover, Blindsight setsTwo-Phase Objectives：

Vision will first beLow Resolution, just like Atari graphics (pixel art style).

Final appearanceGeordi La Forge(A blind character from Star Trek who possesses vision far surpassing that of ordinary humans by wearing a device), capable of seeing in infrared, ultraviolet, and even radar wavelengths.

Following the announcement,Over 20 millionNetizens rushed to witness the scene, exclaiming in disbelief!

incredible！

Some even joked that the last person to cure blindness was Jesus.

Brain-Implanted Chip Blindsight: Restoring Sight to the Blind

As early as March this year, Musk announced that Blindsight would be the next-generation product following “Telepathy.”

In Lao Ma’s words, Blindsight can achieve:

Enabling individuals who have lost their eyes and optic nerves to see.
If the visual cortex is intact, it can even allow those born blind to see for the first time.

At the time, he stated that the Blindsight implant had already beenMonkeyIt took effect in the body.

Generally speaking,Ocular ImagingThe principle is mainly:

When light enters the eye, it first passes through the cornea and lens, which constitute the outer and middle layers of the eye, respectively. Upon reaching the retina at the back of the eye, specialized cells known as photoreceptors convert the light into electrical signals. These signals are then transmitted via the optic nerve to the brain, where they are interpreted as visual images. Visual impairments all result fromDamage to the Retina or Optic Nerve。

Meanwhile, Blindsight is implanted into the brain via an invasive approach, directly stimulating the visual cortex through external electrical signals to enable blind individuals to perceiveLight Perception(perceiving the specific location of light within the visual field).

After the patient provides feedback on the perceived location of light to the researchers, the researchers will again deliver the designed combination of electrical stimulation signals, thereby forming visual patterns within the patient’s field of vision.

According to Old Ma, this methodCompletely bypassing the eyes and optic nerve, sending information directly to the brain, so as long as the visual cortex is intact, even people who are born blind can be "cured."

FDA “Breakthrough Device Designation” ≠ A Cure for Blindness?

Is the truth really as Lao Ma claims?

Foreign media outlet TechCrunch directly commented in a report:

No matter what Musk says, even if Blindsight receives relevant certification,Nor does it mean that Neuralink has developed a treatment for blindness.

Let’s first examine what the FDA’s “Breakthrough Device Designation” actually is.

It is understood that,“Breakthrough Device Designation”(Breakthrough Device Designation) is a special designation provided by the FDA for certain medical devices with the potential to offer breakthrough medical treatments, diagnostics, or monitoring capabilities.

To obtain this certification, one must meet at least one of the following criteria:

This device provides treatment or diagnosis for serious diseases or incurable human diseases or conditions.More Effective Treatment or Diagnosis；

The deviceRepresents Breakthrough Technology, with no approved or authorized alternatives, or demonstrating significant advantages in reducing hospitalizations, improving patients' quality of life, and enhancing patients' self-care capabilities;

Certainly, this certification also provides some additional benefits, such as priority review and other facilitation measures.

Provide several different options for communicating with FDA experts to effectively address issues arising during the premarket review stage;
Priority Review granted by the FDA;

Data shows that the “Breakthrough Device Designation” is aVoluntary Program, since its launch in 2015, there have been nearly1,000 TypesMedical devices received authorization, with 145 types approved last year alone.

Although Blindsight has most recently received certification, TechCrunch views it as follows:

It is still too early to claim that this device can restore sight to the blind.

The issues mainly lie in two aspects:

The primary challenge isLower electrode density。

Although Blindsight increases the density of microelectrode arrays, fundamental flaws remain.
Due to the low density of the electrode array, the “seen” images lack discernible patterns.

Furthermore, it is argued that individuals who are blind from birth do not develop the biological capacity for vision through the eyes; consequently, they lack the visual concepts understood by those with normal sight.

However, most people still holdOptimistic Attitude, believing that full vision restoration is still in its early stages.

Neither Musk nor Neuralink has responded to media requests for comment.

Finally, Neuralink launched another round of advertising to continue recruiting patients for its brain-computer interface trials.

What are your thoughts on this new device?

Reference Link:
[1]https://x.com/elonmusk/status/1836120537883644049
[2]https://x.com/neuralink/status/1836118060308271306

Source: QbitAI

For academic sharing only. If there is any infringement, please leave a message and it will be deleted immediately!

   Join the Community   

Welcome to the Brain-Computer Interface Community Group Chat,

Exploring Topics in the Field of Brain-Computer Interfaces: Real-Time Tracking of Frontiers in Brain-Computer Interface Technology

Join WeChat Group:

Add WeChat: RoseBCI [Note: Name + Industry/Profession].

Join QQ Group: 913607986

   Submissions Welcome   

1. Submissions welcome. For submission inquiries, please contact us on WeChat: RoseBCI

Click to Submit:Guidelines for Submitting Academic News to the Brain-Computer Interface Community

2. To join the community as a part-time creator, please contact us on WeChat: RoseBCI

One-click Triple Action: "Share," "Like," and "Watch"

Stay Ahead of Every Breakthrough in Brain-Computer Interface Technology