Medtech maker Vittamed won CE Mark approval for a pair of ultrasound-based systems for monitoring intracranial pressure and cerebral perfusion, the company announced.
European regulators approved Vittamed’s 205 intracranial pressure measurement and the 505 cerebrovascular autoregulation monitor, both of which use non-invasive headsets to monitor activity in the brain.
The company’s flagship devices aim to provide alternatives to more invasive brain monitoring systems at a lower cost to healthcare providers, according to CEO Dr. Remis Bistras.
"Invasive options for intracranial pressure measurement and for cerebral perfusion monitoring have historically been limited by risk, inconvenience, and high costs," Bistras said in prepared remarks. "Our monitors, in contrast, add no material risk. They are totally non-invasive and may be deployed routinely whenever and wherever indicated, including the outpatient setting."