CorTec has announced FDA approval of an investigational device exemption (IDE) application for its closed-loop brain-computer interface (BCI), allowing the University of Washington School of Medicine (UW) to evaluate the Brain Interchange implant system in a clinical study. This study will explore a novel stroke rehabilitation treatment using cortical stimulation to enhance brain plasticity. CorTec's Brain Interchange system, designed to deliver fully implantable, closed-loop BCI, offers new possibilities for individualized treatments by interchanging information between the brain and computer.
The first IDE study, conducted by teams at UW and UCLA, will focus on obtaining initial safety data and developing novel rehabilitation approaches for upper limb impairment in stroke patients through direct cortical electrical stimulation. Funded by the NIH, the study plans to begin enrollment in the third quarter of 2024, with the first implant scheduled for the same period. This study marks a significant step in using CorTec's technology to advance neuromodulation and BCI research.
CorTec's CEO, Dr. Oliver Baertl, expressed excitement over the FDA's feedback, emphasizing the importance of this approval for supporting clinical research in the rapidly growing BCI space. He anticipates many more studies with the device, with the first human use being a crucial milestone for both the technology and the company.
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