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May 07, 2020

Bittium BrainStatus™ Product Family Received Medical Device Approval in Europe

Press Release

Free for release on May 7, 2020 at 11.00 am (CEST +1)

Bittium BrainStatus™ Product Family Received Medical Device Approval in Europe

Oulu, Finland, May 7, 2020 – Bittium BrainStatus™ product family has received medical device approval in Europe (directive 93/42/EEC). Bittium BrainStatus™ product family is a compact wireless EEG measurement system for the brain's real-time electrical activity monitoring. It is designed for emergency, acute and intensive care use. Its ease of use enables high-quality EEG measurements by both paramedics and clinicians quickly and easily.

Bittium BrainStatus™ product family consists of a wireless compact EEG amplifier, EEG measurement software, and a disposable electrode headband that is quick to wear below the hairline. Bittium BrainStatus can be used for real-time remote EEG monitoring for patients with altered levels of consciousness e.g. epileptic seizures or detecting effects of brain hypoxia.  The system enables quick measurements also in field conditions. Remote diagnosis can be done regardless of the patient's or clinician's location, which makes the treatment process faster for the patient.

Bittium BrainStatus™ device is a compact, wireless and rechargeable EEG amplifier designed for use with Bittium BrainStatus electrode. The amplifier is lightweight and easy to use with high signal quality, enabling long term EEG measurements.

Bittium BrainStatus™ electrode is a novel EEG electrode, made to answer the diagnostics problems in emergency dispatch and other applications which require fast and easy EEG readouts. Bittium BrainStatus electrode is disposable, and unlike traditional headbands, it is placed on the hairless area on the patient's head. This makes proper placement easier and faster, without moving the patient's head.

Bittium BrainStatus™ software is designed for touch panels making it easy and intuitive for users not familiar with EEG devices and software and thus does not require prior knowledge of them. However, it has all the standard features EEG technicians and neurophysiologists expect. Software records EEG locally and it enables the same EEG to be reviewed from other EEG workstations throughout the hospital using a network file server.

Bittium BrainStatus™ server software provides remote access features, including support for mobile networks and centralized storage which improve flexibility and expand the use of the system to regional or service provider use.

BrainStatus supports EEG trend analysis tools as add-on modules for the system. The integrations for the first supported analysis modules will be released in the near future.

More information on the offering:

Further information:

Arto Pietilš
Senior Vice President, Medical Technologies
Tel. +358 (0)40 3443507


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Bittium specializes in the development of reliable, secure communications and connectivity solutions, leveraging its 30 year legacy of expertise in advanced radio communication technologies. Bittium provides innovative products and services, customized solutions based on its product platforms and R&D services. In the field of healthcare technology, Bittium offers solutions for the measurement and monitoring of biosignals in the areas of cardiology, neurophysiology, rehabilitation, occupational health and sports medicine. Net sales in 2019 were EUR 75.2 million and operating profit was EUR 6.3 million. Bittium is listed on Nasdaq Helsinki.