Neuralink Brain Implant Wins an FDA Nod to Tackle Blindness

Neuralink, the medical technology company founded by Elon Musk, received an important clearance from the Food and Drug Administration that may allow the brain implant system to help people with vision problems. The implants are already wired deeply into the brains of two paralysis patients, who’ve shown remarkable progress in being able to interact with digital tech using their thoughts alone. 

The company celebrated news of its FDA approval with a simple post on X: “We have received Breakthrough Device Designation from the FDA for Blindsight,” it said, adding a call for interested people to join the company in its “quest to bring back sight to those who have lost it. Apply to our Patient Registry and openings on our career page.” These words may show how quickly the company wants to progress into real human trials now that it’s received the breakthrough-device approval. 

News site TechCrunch explained that this approval isn’t quite the same as the FDA’s system for approving medical devices for general sale. Rather, the breakthrough designation opens up a voluntary system that allows device makers to interact with FDA experts to help it progress through the “premarket review phase.” It also sets up recipients for priority FDA review once a device is ready.

Neuralink owner Musk sees things differently, and celebrated the approval with his traditional tech-forward bluster. “The Blindsight device from Neuralink will enable even those who have lost both eyes and their optic nerve to see,” he said in a post on X. Under the condition that the patient’s visual cortex–the region of the brain that processes signals from the eyes–is intact, Neuralink may even “enable those who have been blind from birth to see for the first time,” Musk suggested. Unusually for the man, who does love over-enthusiastic expectations (see his wild visions and plans for landing humans on Mars) Musk did course-correct at the end of his post. “To set expectations correctly, the vision will at first be low resolution, like Atari graphics,” he said.

So how does Blindsight work, and why’s it different from earlier Neuralink experiments?

Neuralink’s breakthrough device involves threading a very fine array of hundreds of electrodes deep into patients’ brains. The electrodes are packed along thin wires that send data back to the outside of the skull, and then, with the help of some computer processing and AI, the patient’s neural activity is detected and translated into commands that move a cursor on a computer screen. The first patient, Noland Arbaugh, was quickly using the system to play his favorite computer game, for example–well enough to beat his friends, news site PCMag reported.

Blindsight is different. It’s essentially a more advanced version of earlier tech that recorded some very limited success in the 1990s with patients who’d lost their natural vision. In the updated version, Neuralink device threads would target a different portion of patients’ brains, the visual cortex. The array of hundreds of electrodes wouldn’t be used to detect brain activity, but instead stimulate it with tiny bursts of electricity. Hence Musk’s reference to “Atari graphics,” which were the low-resolution, slow, and initially monochrome graphics that typified computer gaming in the 1980s. The intention is that by adapting which electrodes send electrical pulses in the right way to the right brain regions, the patients’ brains will be able to process the signals as images, similar to the natural process where data travels along the optic nerve, and thus give them back a limited form of vision.

What about Musk’s personal vision of the future? It’s crystal clear: In his X post he also said he thinks Neuralink has the potential to “be better than natural vision and enable you to see in infrared, ultraviolet or even radar wavelengths, like Geordi La Forge.” Here he’s referencing the iconic blind Star Trek character who uses a futuristic artificial vision device that’s implanted into his brain. Elon Musk: Boldly going there. ​