Cortec has received the status of “breakthrough device” from the US drug agency FDA. This classification relates to the ‘Brain Interchange System’, a fully implantable brain-computer interface (BCI), which is intended to support the motor rehabilitation of stroke patients. The system combines the capture of brain signals with adaptive stimulation in a closed loop system. This distinguishes it from other BCIs, which primarily serve to control external devices. The system is currently being tested in a FDA-approved clinical study at the University of Washington in Seattle. The term ‘breakthrough device’ is intended for technologies that enable more effective treatment of life-threatening or irreversibly damaging diseases. It grants developers a prioritized review and closer interaction with regulators. Cortec sees itself as a pioneer in the global BCI market, as the company combines a bidirectional closed-loop system with therapeutic approaches to restore motor functions.
via roboticsandautomationnews.com