Elon Musk’s brain-chip startup Neuralink disclosed recently that its experimental implant to restore vision received the U.S. Food and Drug Administration’s “breakthrough device” designation. But even this accelerated-review process will take years:
The FDA’s breakthrough tag is given to certain medical devices that provide treatment or diagnosis of life-threatening conditions. It is aimed at speeding up development and review of devices currently under development.
The experimental device, known as Blindsight, ‘will enable even those who have lost both eyes and their optic nerve to see,’ Musk said….Founded in 2016 by Musk and a group of engineers, Neuralink is building a brain chip interface that can be implanted within the skull, to help disabled patients to move and communicate again, and also restore vision.
Neuralink’s device has a chip that processes and transmits neural signals that could be transmitted to devices like a computer or a phone. The startup is separately testing an implant designed to give paralyzed patients the ability to use digital devices by thinking alone, a prospect that could help people with spinal cord injuries.
This trial is expected to enroll three patients to evaluate its device in a study expected to take several years to complete, according to details on the U.S. government’s clinical trials database. Earlier this year, Neuralink successfully implanted the device in the second patient, who has been using it to play video games and learn how to design 3D objects.
Without a “breakthrough device” designation, it would take even longer to approve this implant. The FDA can take many years to approve medical devices and drugs. The FDA didn’t approve a home test for HIV until 24 years after it first received an application. According to an FDA advisory committee, the test held “the potential to prevent the transmission of more than 4,000 new HIV infections in its first year of use alone.” That means thousands of people likely got infected with AIDS as a result of the delay in approving it. At least a hundred thousand people died waiting years for the FDA to approve beta blockers.
A recently-developed brain implant lets people control Alexa with their mind. Skull implants could fight depression.
Brain implants are also being used to restore cognitive abilities wiped out by traumatic brain injuries, enabling people to work again, and once again do things they couldn’t do because of their brain injury, such as reading, avoiding getting speeding tickets, and grocery shop.
A brain implant helps a stroke survivor communicate in two languages.
Scientists have developed tiny robots made of human cells to repair damaged cells. Scientists “have successfully programmed nanorobots to shrink tumors by cutting off their blood supply.”
Artificial intelligence is now developing highly-effective antibodies to fight disease. Doctors overseas are using artificial intelligence to detect cases of breast cancer more effectively.
