Neuralink's Breakthrough Device Clearance from FDA Does Not Mean It Has Cured Blindness

On Tuesday, Neuralink, the brain-computer interface company owned by Elon Musk, received "breakthrough device" clearance from the Food and Drug Administration (FDA). However, this development does not imply that the company has developed a cure for blindness, as some might infer from Musk’s statements.

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Understanding the Breakthrough Devices Program

The breakthrough devices program at the FDA is a voluntary initiative that allows developers to apply for designation. If granted, this designation offers manufacturers an opportunity to interact with FDA experts through various program options to efficiently address topics during the premarket review phase. Additionally, it ensures priority FDA review.

A Brief History of Breakthrough Devices

Since its inception in 2015, over 1,000 medical devices have been authorized through the breakthrough designation program. In 2023 alone, 145 devices received this designation. Neuralink’s Blindsight is the latest recipient of this designation.

What is Blindsight?

Blindsight is a new iteration of technology that has been used for decades to experimentally restore limited vision to blind individuals. A microelectrode array is embedded in the visual cortex and stimulates neurons located there in patterns derived from a camera. This creates visual phenomena in people who may have never seen before.

Musk’s Overly Ambitious Claims

Elon Musk wasted no time asserting that Blindsight will enable those with lost vision to see, including those who have been blind since birth. However, it is premature to make such claims. The technology suffers from a fundamental drawback: the low density of electrodes on the array.

The Limitations of Neuralink’s Approach

While Neuralink has made progress in increasing electrode density, its approach still faces significant challenges. Even among those who have recently lost their sight due to trauma or disease, sight restoration would not be as straightforward as Musk suggests. The visual cortex requires extensive training and adaptation to function normally.

Implications for People Born Blind

Individuals born blind will not possess the biological capacity for seeing through their eyes, meaning that despite the optimized cellular layout in the visual cortex, the pathways that create the concept of vision will not exist.

A More Realistic Outlook

While it is irresponsible to make bombastic promises like Musk has done, Neuralink’s contributions are still valuable. The company’s research and innovations may eventually contribute to a future where electronic implant-based treatments for blindness become realistic. If only Neuralink were more transparent in their research and discussions with experts.

The Need for Transparency

As the FDA grants Neuralink permission to proceed with its device, it is essential that the company operates more openly. This would facilitate a more open discussion among domain experts about the merits and challenges of this approach. Only through transparency can we ensure that the development of such technologies aligns with the needs of those who will benefit from them.

Conclusion

The breakthrough designation granted to Neuralink’s Blindsight is a significant step forward in the field of brain-computer interfaces. However, it is essential to maintain a realistic outlook and not make unsubstantiated claims about the potential benefits of this technology. By doing so, we can ensure that the development of such technologies prioritizes the needs and well-being of those who will benefit from them.