CE mark approval for device to assist in rapid ischaemic stroke triage


Cerebrotech Medical Systems has received the CE mark for detection of bioimpedance asymmetry associated with stroke. This latest certification for Cerebrotech’s Intracranial Fluids Monitor (ICF) is in addition to the previous indication for use in detecting changes to intracranial fluids in patients at risk for oedema.

The Intracranial Fluids Monitor is a non-invasive bioimpedance spectroscopy device designed to detect changes and distribution of brain fluids. Recent data from Cerebrotech’s sponsored clinical research has demonstrated that the device can detect fluid asymmetry between the left and right hemispheres induced by large vessel ischaemic strokes. In under a minute, the device can recognise bioimpedance asymmetry signals associated with stroke in patients experiencing stroke symptoms.

“Our ability to quickly assess and respond to strokes is critical to ensuring good outcomes for our patients,” says Wade Smith, Daryl R Gress Endowed Professor of Neurocritical Care and Stroke at University of California San Francisco, USA and chairman of the company’s Scientific Advisory Board. “Having access to a device that can give us this information rapidly has the potential to significantly change the clinical paradigm for emergency stroke care.”

“European regulatory clearance in this emergency stroke application is a significant milestone for the company, and paves the path to commercialisation,” says Mitch Levinson, president and CEO, Cerebrotech Medical Systems. “We are looking forward to advancing the state of stroke care with our wireless and non-invasive approach to intracranial monitoring.”

Cerebrotech employs proprietary machine learning and artificial intelligence software to train the system to detect bioimpedance frequency response patterns associated with neurological conditions. The company has plans to train the Intracranial Fluids Monitor to detect a variety of disease states, including stroke, cerebral oedema, traumatic brain injury, hydrocephalus, concussion, and brain tumours. The device is not yet cleared for sale in the USA.


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