USA: CorTec receives permission for brain implant experiments with humans

Published on October 14, 2024

The German company CorTec will soon be able to implant its Brain Interchange System in humans in the USA. The Institutional Review Board (IRB) of the University of Washington approved a feasibility study. The Freiburg company's brain-computer interface is intended to be used for rehabilitation after a stroke.

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CorTec had previously received approval from the US Food and Drug Administration (FDA), which assesses the technical safety and performance as well as the quality of the study planning. The next step is to recruit volunteer study participants, the company announced on Monday. To obtain approval, both the research team at the University of Washington and device manufacturer CorTec had to submit numerous documents. "The FDA's assessment focused on the study protocol, the hazard analysis and the device design to ensure suitability for implantation in humans," explains Jeffrey Herron, a professor at the University of Washington who is supervising the study on site and describes the approval as a crucial milestone.

Rehabilitation for impairments after a stroke

"Our system enables a seamless exchange of information between biology and technology, which is why we called it CorTec Brain Interchange," says Martin Schüttler, CTO of CorTec, about the closed-loop functionality of the Brain Interchange System. As a technological tool, the product opens up ways to develop new therapies. By electrically stimulating the surface of certain areas of the brain, the device is intended to support rehabilitation when those affected suffer from impairments of the upper limbs as a result of a stroke.

The Freiburg-based company CorTec has been around since 2010. The company markets neurotechnology for clinics and industry, including systems for researching new clinical applications. The Brain Interchange System is fully implantable. It works on 32 channels both sensory and stimulating. The purpose of the system is to research new therapies for the central nervous system.

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Source: heise online