FDA&CE approval for VEEGix, EEG device designed and manufactured by NeuroServo


VEEGix is a young company who designed and is manufacturing VEEGix, an innovative, medical grade prefrontal EEG: miniaturized, wireless, single-use dry electrodes, with realtime brainwave analysis and pathology detection.

VEEGix has been designed to be used as an emergency EEG for ICU/ER, as a screening device (post-operative delirium) and as a CFM (cerebral brain monitor).

VEEGix is an IoT in the sense that the equipment allows the capture of EEG in environments outside hospitals (ex: postoperative follow-up in CHSLD) or in remote and isolated hospitals (ex: taking EEG measurements in the Far North of Quebec with transmission to a specialist in a large center).

VEEGix has obtained all medical certifications (IEC / EN 60601, 80601-2-26) and NeuroServo has obtained ISO 13485: 2016 certification granting it the quality of medical manufacturer, allowing it to produce its own equipment.
Recently (October 2021), Health-Canada has authorized the marketing of VEEGix.

NeuroServo now wishes to apply for authorization to market VEEGix in the United States and in Europe and must apply to the FDA and to European agencies.

NeuroServo requests the support of the HI_DOS program in this important step.