USA: CorTec receives permission for human brain implant trials
The Freiburg-based company CorTec has received permission to test its Brain Interchange System on humans. The implant is intended to help after strokes.
After Neuralink, CorTec is now also allowed to use its Brain Interchange System in humans.
(Image: Skorzewiak/Shutterstock.com)
The German company CorTec will be allowed to implant its Brain Interchange System in humans in the USA in the future. The Institutional Review Board (IRB) of the University of Washington approved a feasibility study. The brain-computer interface from the Freiburg-based company is intended for rehabilitation after a stroke.
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 design. The next step is now to recruit volunteers for the study, the company announced on Monday. Both the research team at the University of Washington and device manufacturer CorTec had to submit numerous documents for approval. "The FDA's evaluation focused on the study protocol, hazard analysis and device design to ensure suitability for implantation in humans," explains Jeffrey Herron, professor at the University of Washington, who is supervising the study locally, and describes the approval as a decisive milestone.
Rehabilitation for impairments after stroke
"Our system enables a seamless exchange of information between biology and technology, which is why we called it CorTec Brain Interchange," says Martin SchĂĽttler, 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 for people suffering from upper limb impairment as a result of a stroke.
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CorTec, a Freiburg-based company founded in 2010, markets neurotechnology for clinics and industry, including systems for research into 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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