Cognixion Brain-Computer Interface Gets Breakthrough Designation for Paralyzed Patients

Cognixion has received Breakthrough Device designation for its Cognixion ONE noninvasive brain-computer interface that combines artificial intelligence with augmented reality and assistive technology to allow people with severe motor impairments to communicate more effectively.

The device uses non-invasive electroencephalogram technology that enables patients with neurodegenerative conditions such as amyotrophic lateral sclerosis (ALS) or acquired conditions such as severe injuries or cerebral palsy “to communicate their responses with their thoughts and mental attention in a wearable, augmented reality headset,” the company said.

“No such cleared device exists which can allow fully paralyzed or locked-in patients to communicate once the current standard of care, eye-tracking” is no longer possible for the patient, the company said.

The FDA Breakthrough Device program gives timely access to medical devices by speeding up their development, assessment and review.

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