Elon Musk’s Neuralink Gets US Drug Regulator's "Breakthrough" Tag For Speech-Restoring Brain Device

Elon Musk's neurotechnology company Neuralink announced on Thursday (1 May) that it has received the US Food and Drug Administration's "breakthrough" tag for its device to restore communication for individuals with severe speech impairment.

"We've received Breakthrough Device Designation from the FDA to help restore communication for individuals with severe speech impairment," Neuralink said in a post on X.

According to the company, the device would help those affected by amyotrophic lateral sclerosis (ALS), stroke, and other neurological conditions.

"This includes those affected by ALS, stroke, spinal cord injury, cerebral palsy, multiple sclerosis, and other neurological conditions," the company said.

The FDA Breakthrough Device Designation is a programme that expedites the review and approval of medical devices with the potential to significantly improve the treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

It provides manufacturers with faster regulatory pathways, priority review, and guidance from the FDA.

This programme aims to accelerate the availability of groundbreaking medical technologies to patients.

Earlier in September last year, Neuralink's experimental implant aimed at restoring vision had also received the US Food and Drug Administration's "breakthrough device" designation.

The experimental device, known as Blindsight, "will enable even those who have lost both eyes and their optic nerve to see," Musk had said in a post on X.

Also Read: Vizhinjam International Seaport: PM Modi To Commission India's First Dedicated Container Transshipment Port