Elon Musk’s Neuralink wins FDA breakthrough tag for Blindsight device

Elon Musk-owned neurotechnology firm Neuralink has received the U.S. FDA’s breakthrough device designation for its experimental brain implant, Blindsight, designed to restore vision.

With its breakthrough devices program, the agency expects to speed up the development and review of more innovative medical devices, helping developers accelerate their market access.

Among its benefits, manufacturers with breakthrough device designations can seek FDA-priority review for their regulatory submissions.

Musk, the CEO of EV maker Tesla (TSLA) and space exploration company SpaceX (SPACE), welcomed the FDA’s decision shortly after Neuralink announced the designation.

“The Blindsight device from Neuralink will enable even those who have lost both eyes and their optic nerve to see,” he said.

Neuralink has already treated two patients in its FDA-cleared PRIME study for its brain-computer interface (BCI), designed to help patients with neurological conditions control external devices, such as computers, only with their thoughts.