Bengaluru: Elon Musk’s controversial brain-computer interface start-up Neuralink has been granted approval from the US Food and Drug Administration (FDA) for its upcoming product Blindsight. The company claims that with this device, permanent blindness, including congenital loss of vision, can be completely reversed.
The FDA approval came under a “breakthrough device” tag, a category usually assigned to medical devices that necessitate human testing. However, despite the claims, Musk, to temper expectations, included a disclaimer when announcing the product, noting that initial results would be similar to low-resolution graphics.
ThePrint explains what this latest breakthrough device is, its potential, and Neuralink’s contentious work over the years.
What is Blindsight & how will it work
Blindsight is a brain-computer interface (BCI) device, or a chip, surgically implanted in the brain, that will enable those who are blind to see. It will only work for those who have suffered damage to their optic nerve, but not the visual cortex of the brain which processes imagery and input from the eyes.
The device will enable transmission of signals by bypassing the optic nerve and directly stimulating the visual cortex of the brain to make imagery visible to those without eyesight.
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What Neuralink does
Neuralink is a neurotechnology company that develops implantable BCIs. These devices connect the brain and a computer, as their name suggests, and instructions through the computer can be utilised to send electrical signals to the device, and vice-versa.
The device can decode electrical signals from the brain and translate them externally. This means it can create pixelated visuals from someone’s dream, or send instructions to the computer, which result in electrical signals stimulating certain nerves resulting in, for instance, a limb motion in someone who is paralysed. BCIs can be implantable inside the brain, or also be non-invasive—in the form of electrodes attached to the skull.
Neuralink device is placed inside the brain and is implantable through extremely thin probes inserted into the brain robotically. However, the details of the technology are not available to the public.
In 2017, Neuralink began animal trials in live monkeys, pigs, and other mammals, which was promptly followed by multiple allegations of animal abuse from research and welfare advocacy groups in the scientific community. In May 2023, after previous rejections of approvals for human testing, the US FDA approved human clinical trials. In September, Neuralink began human trials among people who have had spinal cord injury and lost the use of all four of their limbs, or had them amputated.
The first person to receive the chip in March of this year demonstrated the ability to move a cursor on a screen with thought, although it was later revealed that 85 percent of the implant, called Telepathy, had detached and his brain had moved. The second person in the trial received the implant last month.
Why Neuralink was investigated by authorities & other controversies
During its animal testing phase in 2017—which Neuralink conducted in academic partnership with University of California-Davis—its experiments included the use of over 25 monkeys, of which, scientific animal welfare groups alleged at least 15 were mistreated.
Allegations from the Physicians Committee for Responsible Medicine, which acts as a watchdog for medical research, included indiscriminate euthanasia, extreme psychological distress, unnecessary suffering and pain, and chronic infections in the animals due to implant surgeries. The group also alleged UC Davis withheld photographic evidence of animal abuse.
In February of 2022, Neuralink stated that the macaque monkeys in the experiments were euthanised after experiments and denied animal abuse.
In December, Neuralink came under investigation by the United States Department of Agricultures (USDA) for animal welfare violations. The US FDA at this time also rejected a 2022 application for human clinical trials due to safety concerns involving the device’s battery as well as damage to the brain tissue when removing the device.
Meanwhile, journalistic outlets published investigations into the work culture inside the company.
A Reuters report quoted Neuralink employees stating that testing in animals was being rushed leading to mistreatment and suffering among animals due to Musk’s demand for quick results. A Wired report quoted former employees and exposed public record details of animal injuries and infections, including paralysis, loss of fingers, and swelling of the brain after implantation of the device. Another report last year from Wired alleged that Neuralink had actively worked to hide details of animal suffering from the public.
In November 2023, lawmakers in the US requested the Securities and Exchange Commission, which investigates market manipulation, to investigate if Neuralink cheated investors by hiding details of animal deaths.
Apart from issues with animal testing, the company also faced strife internally, with many of its founding, high-profile neuroscientists engineers eventually leaving the company. By 2020, five of the eight founding scientists had quit. STAT News reported that Neuralink went head-to-head with its teams over rushed deadlines. A year later, another co-founder and then-president Max Hodak also left the company.
The present state of BCI research globally
BCI research has been around since at least the 1970s, when defence research at UCLA introduced the term BCI. The first devices were implanted into the human brain in the 1990s and worked towards solving basic challenges.
In the 2000s, many breakthroughs were made in animals. Monkeys were used by many research groups in various universities to move cursors and play games with joysticks using robotic arms. Researchers have managed to use BCI to stimulate limb movement in individuals with paralysis, synthesize speech and imagery from the brain signals of someone dreaming, provide auditory output for those with speech impairments, and even create visual experiences directly in the brain of a visually impaired person, among other groundbreaking applications.
Stimulating vision in those who became blind later in life through BCI has been happening since the late 1990s. In 2002, visually impaired patients were able to drive a car slowly, albeit the effect lasted only temporarily.
The procedure of invasive BCIs still comes with risks owing to the very delicate location of where it is housed—the brain, whose functioning is vital to life. Surgeries to implant BCIs, which are foreign objects, can potentially result in tissue damage, build-up of scar tissue, immune reaction, and more.
What’s next with Blindsight
In March of 2024, Musk announced Blindsight and stated that the company was already working on animal trials with monkeys. He said that the imagery obtained by the visual cortex is blurry and is low resolution, but is expected to improve.
Phase 1 of human clinical trials will test for safety first over efficacy. Therefore, just like the Telepathy implant, Blindsight will also be implanted in single individuals who will be monitored closely.
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