Skip to main content

Cortical's BAR Monitor receives CE Mark

Cortical Dynamics Ltd (“Cortical”) is pleased to announce it has received formal notification from the Therapeutic Goods Administration (“TGA”) that a decision has been made to issue MRA EC certificates (“CE Mark”) to Cortical under the Mutual Recognition Agreement (MRA) with the European Union therefore allowing the  CE mark to be applied to the BAR monitor.

In November 2015 Cortical’s Brain Anaesthesia Response (“BAR”) monitor was formally included on the Australian Register of Therapeutic Goods.

Having achieved TGA certification and the CE Mark, Cortical is now able to market the BAR monitor within Australia and Europe.

Cortical’s Chairman Mr David Breeze said “This is an extremely significant development for Cortical. We are now in a position to market the BAR in one of the worlds’ largest EEG brain function monitoring equipment markets. The global brain monitoring market is valued in excess of $1 billion.”

Cortical will initially focus on the Total Intravenous Anaesthesia (“TIVA”) market within Europe. TIVA provides a method of inducing and maintaining general anaesthesia without the use of any inhalation agents.

The European healthcare body NICE (National Institute for Health and Care Excellence) has recommended EEG (electroencephalogram) based depth of anaesthesia monitors as options in patients receiving TIVA and in patients who are considered at higher risk of adverse outcomes during any type of general anaesthesia.

This includes patients at higher risk of unintended awareness and/or excessively deep anaesthesia.

It is estimated by the Society of Intravenous Anaesthesia that the TIVA usage has already reached approximately 40% of all anaesthesia procedures in Italy.

For more information refer to the announcement here