Brain monitor dev Cerebrotech Medical Systems said today it won expanded CE Mark approval in the European Union for its portable brain bioimpedance monitor with indications for detecting bioimpedance asymmetry associated with stroke.
The certification expands previously won clearance which indicated the device for use in detecting changes to intracranial fluid in patients at risk for edema, the Pleasanton, Calif.-based company said.
“Our ability to quickly assess and respond to strokes is critical to ensuring good outcomes for our patients. 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,” scientific advisory board chair Dr. Wade Smith of the University of California San Francisco said in a prepared statement.
Cerebrotech’s Intracranial Fluids Monitor is a non-invasive bioimpedance spectroscopy device designed to detect changes and distribution of brain fluids, and has been shown to detect fluid asymmetry between the left and right hemispheres induced by ischemic strokes in recent clinical trials.
“European regulatory clearance in this emergency stroke application is a significant milestone for the company, and paves the path to commercialization. We are looking forward to advancing the state of stroke care with our wireless and non-invasive approach to intracranial monitoring,” prez & CEO Mitch Levinson said in a press release.