Elon Musk’s brain-computer interface company, Neuralink, has announced that it has received the United States Food and Drug Administration’s “breakthrough device” designation for a new implant designed to help individuals with severe speech impairments.

In a post on social media platform X on Thursday, the company revealed that the device is intended to assist people affected by neurological conditions such as amyotrophic lateral sclerosis (ALS), stroke, spinal cord injuries, cerebral palsy, multiple sclerosis, and similar disorders that hinder verbal communication.

The FDA’s breakthrough devices program aims to accelerate the development, evaluation, and regulatory review of innovative medical technologies that offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions.

By securing this designation, Neuralink’s device will benefit from closer collaboration with the FDA during its development, potentially expediting its path to clinical use and approval.

Neuralink is already conducting clinical trials for its brain implants, which aim to connect the human brain to computers, enabling users to control devices and communicate through neural signals.

The company has positioned this latest device as a significant step toward improving quality of life for patients who have lost their ability to speak due to severe neurological damage.