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CorTec Receives FDA Breakthrough Device Designation for Its Brain Interchange System in Stroke Rehab

09.04.2026

CorTec Receives FDA Breakthrough Device Designation for Its Brain Interchange System in Stroke Rehabilitation

Freiburg, Germany, April 08, 2026: CorTec GmbH, a pioneer in fully implantable brain-computer interfaces (BCI), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Brain Interchange™ system. The designation covers the use of direct cortical electrical stimulation to support motor recovery in people living with chronic stroke-related impairments. 

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Pressemitteilung CorTec

CorTec GmbH
Neuer Messplatz 3
79108 Freiburg
Medical Device manufacturer | neuromodulation | active implants