CorTec Receives Second FDA Breakthrough Device Designation for Brain-Computer Interface
核心洞察
CorTec (搜索) received a second FDA Breakthrough Device Designation for its Brain Interchange (搜索) brain-computer interface, this time covering communication for people with non-progressive quadriplegia (搜索).
The designation covers use of the implantable BCI to let people with paralysis in all four limbs control a computer cursor through neural signals.
The first designation, granted in April 2026, covered stroke (搜索) motor rehabilitation, which remains CorTec (搜索)'s lead clinical program in an IDE study at the University of Washington.
CorTec (搜索) has received a second US Food and Drug Administration Breakthrough Device Designation for its Brain Interchange (搜索) brain-computer interface, this time covering communication for people with non-progressive quadriplegia (搜索). The designation covers use of the implantable BCI to enable people with paralysis in all four limbs to control a computer cursor through neural signals, giving them an independent means of interacting with computers and other digital systems.
The Freiburg, Germany-based neurotechnology company received its first Breakthrough Device Designation for Brain Interchange (搜索) in April 2026 for stroke (搜索) motor rehabilitation. The FDA grants the designation to technologies with the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions, and the program provides a prioritized, more interactive regulatory review during device development. CorTec (搜索) says the two designations show the same platform can operate as both a therapeutic and an assistive BCI: for stroke rehabilitation it delivers targeted brain stimulation intended to support motor recovery, while for communication it records and decodes neural signals associated with a user's intentions and translates them into digital commands.
Brain Interchange (搜索) is a fully implantable, wireless and battery-free BCI designed to record cortical signals and translate them into digital commands in real time. The system is bidirectional and closed-loop, meaning it can both record neural activity and deliver targeted electrical stimulation, and it uses non-penetrating cortical surface electrodes. Stroke (搜索) motor rehabilitation remains the lead clinical program, evaluated in an FDA-approved Investigational Device Exemption study at the University of Washington in Seattle, where three patients have been implanted to date; CorTec (搜索) says the system has demonstrated more than 500 days of continuous signal stability, with results published in Scientific Data. The platform is also being evaluated in a registered epilepsy (搜索) study at Mayo Clinic, which has enrolled 13 patients, and a communication study in people with paralysis, known as INTENSE, is planned at UMC Utrecht. CorTec says it is developing the technology for further potential indications, including depression (搜索), and is enrolled in the FDA's Total Product Life Cycle Advisory Program for its stroke program.
Source: roboticsandautomationnews.com