CorTec's Brain Interchange Accepted into FDA TAP and Third Patient Implanted
Summary
CorTec announced that the FDA has accepted the Brain Interchange BCI system into its Total Product Life Cycle Advisory Program (TAP), following the recently granted Breakthrough Device Designation. Additionally, a third patient has been successfully implanted at Harborview Medical Center in Seattle as part of the ongoing NIH-funded clinical trial. TAP provides companies with a dedicated FDA liaison and accelerated feedback on study design and regulatory strategy.
Why it matters
TAP acceptance places CorTec among a limited number of neurotech companies to receive both Breakthrough Device Designation and TAP enrollment, providing structured end-to-end support from clinical development through market access and reimbursement. The third patient implantation expands the clinical dataset and demonstrates the system's performance across a broader range of stroke profiles. This dual recognition signals strong regulatory momentum for the Brain Interchange platform.
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