Medical device technology company Brain Scientific has obtained CE Mark for its NeuroCap neurological device.
The NeuroCap is a pre-gelled disposable electroencephalogram (EEG) headset that has been designed to streamline EEG preparation, testing and diagnosis.
It allows healthcare providers to prepare a patient for an EEG exam quickly, eliminating the existing, time-consuming task of measuring and placing electrodes on the patient’s head.
The device features 22 pre-gelled electrodes and 19 active channels, with fixed electrode placement according to the international ten to 20 system.
NeuroCap also has a disposable and single-use EEG headset, which reduces cross-contamination between patients as well as the risk of hospital-acquired infections.
The device has also received 510k clearance from the US Food and Drug Administration (FDA).
It can be used in a broad range of settings, including urgent care clinics, urban and rural emergency rooms, nursing homes, sports facilities, neurology clinics, ICUs, and clinical research studies.
Brain Scientific chairman and CEO Hassan Kotob said: “Our neurology products are accelerating access to EEG testing both in hospitals and in the field.
“The CE mark is a vital step forward as we increase our market penetration in Europe.”
The NeuroCap device is available in four sizes, ranging from paediatric extra-small to adult large.
To determine the correct NeuroCap size, any healthcare worker can measure the circumference of a patient’s head.
Additionally, Brain Scientific has developed NeuroEEG, a 21-channel, portable amplifier.
The device acquires, records and displays the electrical brain activity of a patient on a PC or laptop.