Prolira secures FDA clearance for its DeltaScan brain state monitor
Prolira (Utrecht, the Netherlands) announced today that the FDA has cleared its brain state monitor […]
Prolira (Utrecht, the Netherlands) announced today that the FDA has cleared its brain state monitor to help diagnose acute encephalopathy in older hospital patients.
DeltaScan is for hospitalized patients aged 60 and older. Prolira said it provides a quick and objective measurement of acute brain failure even before symptoms appear. The measurements enable sped-up treatment, helping patients regain cognitive well-being.
“Managing acute encephalopathy is challenging as symptoms are often overlooked and the diagnostic approaches are largely subjective and ineffective, resulting in delayed diagnosis and treatment. This delay often leads to cognitive impairment, worse health outcomes, and increased costs,” Dr. Frans Leijten, head of the EEG Department at UMC Utrecht, said in a news release.
“DeltaScan enables clinicians to objectively identify acute encephalopathy, which encompasses delirium, alerting us to act quickly to determine the underlying cause and appropriate interventions,” Leijten said. “It’s clear from the evidence that minimizing the duration of acute brain failure can improve outcomes.”
More about how Prolira’s DeltaScan works
DeltaScan measures polymorphic delta waves in the electroencephalogram. Nurses or technicians can easily perform a bedside measurement and obtain a negative or positive output in less than 5 minutes, according to Prolira. Hospitals don’t need specialized personnel or complicated equipment to use DeltaScan.
Prolira said a large-scale clinical study of more than 400 ICU and post-operative patients (mostly 60+ of age) demonstrated a diagnostic performance of more than 85% for acute encephalopathy.
“FDA clearance is a major milestone in our mission to make brain state assessments and follow-up interventions an integral part of standard practice. The uptake of DeltaScan in Europe has been strong and has allowed the company to incorporate clinician feedback into the product design, generate robust clinical evidence, and refine our commercial approach,” said Prolira CEO Dominic Spadafore. “We’re excited to bring our unique solution to the U.S. and have developed a robust pipeline of US centers interested in our proven solution.”
Original Article: (https://www.massdevice.com/prolira-secures-fda-clearance-deltascan-brain-state-monitor/)