Neuralink’s Blindsight granted US FDA’s Breakthrough Device Designation
The brain-computer interface implant is designed to help restore blindness by driving neuronal signals in the visual cortex.
Blindsight, a brain-computer interface implant designed to help restore blindness, has been granted Breakthrough Device Designation by the US FDA. It is hoped that the device will be able to restore sight, even in patients who were born blind. Blindsight is designed by Neuralink (CA, USA), Elon Musk’s brain-computer interface startup company.
The device increases visual perception in patients by processing and transmitting neural signals. A microelectrode array is implanted into the visual cortex of the brain to drive neuronal signals, which provide the patient with a visual image. The device therefore relies on the visual cortex being intact to function properly.
The company has managed expectations, explaining that initially vision will be low-resolution like the graphics of early video games. However, the company hopes that it will ultimately exceed normal human vision.
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The FDA’s Breakthrough Device Designation’s purpose is to speed up the process of developing, evaluating and approving medical devices that treat serious or permanent conditions. This special status will allow Neuralink’s Blindsight to be fast-tracked in testing procedures, bringing the device to patients in urgent need. Blindsight has since met the safety requirements necessary to be acknowledged as a breakthrough device, which will help speed the review of its potential premarket approval. There is no currently known date as to when Blindsight will be moved into clinical trials.
Last year, Neuralink received FDA approval for its first clinical study of an implant to enable paralysed patients with spinal cord injuries to operate devices through thoughts alone [1].
However, Neuralink has faced previous criticisms for apparently withholding information about the ongoing trial. Whereas most companies are transparent with their trials’ details as per the industry standard, Neuralink have been criticized for not sharing information about the study in full. This, along with concerns of violating the Animal Welfare Act in preclinical research, do mar the ambitious promises made of the Neuralink’s Blindsight technology [2].