US-based medical device company Brain Scientific announced the Conformité Européenne (CE) Mark for its NeuroCap device.

The CE mark attests to Brain Scientific’s compliance with all standards of the European Medical Device Directive, allowing it to start marketing the device in Europe and other CE mark geographies.

NeuroCap is an FDA-approved, pre-gelled disposable EEG headset for clinical use that is available in four sizes, including paediatric sizes.

Brain Scientific said that any practitioner can get a patient ready for an EEG assessment using the NeuroCap in a fraction of the time it would normally take to apply individual electrodes.

The NeuroCap expands access to EEG testing by being used in almost any setting, including rural hospitals, ambulances, private practises, and sporting events.

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.”

Brain Scientific has created two instruments to simplify EEG preparation, testing, and diagnosis.

With 22 pre-gelled electrodes, NeuroCap is said to be a better alternative for the majority of clinical EEG testing, including common EEGs used for stroke and epilepsy patients.

The fixed electrode implantation is followed by the worldwide 10-20 system, said the company.

A 21-channel amplifier called NeuroEEG offers therapists the same level of quality as conventional EEG equipment.