CorTec Receives FDA Breakthrough Device Designation for Brain Interchange System in Stroke Rehabilitation
Summary
CorTec GmbH announced that the FDA has granted Breakthrough Device Designation for the company's Brain Interchange system for stroke motor rehabilitation. The designation covers the use of direct cortical electrical stimulation to support motor recovery in people living with chronic stroke-related impairments. The system combines neural signal recording with adaptive stimulation in a fully implantable, wireless, bidirectional closed-loop BCI system.
Why it matters
This is the first BCI worldwide to receive FDA Breakthrough Device Designation specifically for stroke motor rehabilitation. Stroke is the leading cause of acquired long-term disability in adults, with approximately 9 million ischemic strokes occurring globally each year. The Brain Interchange system offers a potential therapeutic option for chronic stroke patients whose recovery has plateaued after conventional therapy, addressing a significant unmet medical need.
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