CorTec Becomes First German BCI Company to Receive FDA Breakthrough Device Designation

Summary

The FDA granted Breakthrough Device Designation to CorTec's Brain Interchange system for using direct electrical stimulation of the cortex to aid motor recovery in chronic stroke patients — the first time a BCI company based in Germany has received the designation. The closed-loop system, which combines neural signal recording with adaptive stimulation, has already been implanted in two patients at Harborview Medical Center in Seattle, in July 2025 and February 2026, building on 510(k) clearance for its cortical mapping electrodes in 2019 and an FDA investigational device exemption granted in 2024. CorTec said its first implanted patient has shown meaningful recovery of upper-limb motor function that had previously plateaued under standard rehabilitation.