DeltaScan is a bedside device designed to measure polymorphic delta waves in the electroencephalogram (EEG) to provide clinicians with quick and objective brain state measurements
Dutch medical technology company Prolira has secured the Food and Drug Administration (FDA) 510(k) approval for its DeltaScan Brain State Monitor.
Prolira is a spin-off of the University Medical Centre Utrecht (UMC Utrecht) and is focused on developing therapies for patients at risk of developing acute brain failure.
Its DeltaScan Brain State Monitor is designed to provide a fast and objective measurement of acute brain failure, prior to the onset of symptoms.
The US regulator approved the device to help diagnose acute encephalopathy in hospitalised patients aged 60 years and above.
The technology enables clinicians to provide immediate treatment and help patients regain cognitive well-being, said the medical technology company.
Prolira chief executive officer Dominic Spadafore said: “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.
“We’re excited to bring our unique solution to the US and have developed a robust pipeline of US centres interested in our proven solution.”
Acute brain failure is caused by underlying conditions, including postoperative infections, organ failures, and metabolic disorders, and its early detection may help prevent permanent cognitive dysfunction.
According to the company, about half of the surgical and ICU patients in the US and Europe are at risk of developing acute brain failure and delirium.
However, up to 88% of delirium cases are left undiagnosed, as the most widely used detection tools are checklist-based and subjective.
Prolira said that its DeltaScan Brain State Monitor is the first bedside platform to objectively determine if a patient has acute brain failure even before symptoms occur.
The device measures polymorphic delta waves in the electroencephalogram (EEG).
In a large-scale clinical study of 400 ICU and post–operative patients, DeltaScan showed a diagnostic performance of more than 85% in detecting acute encephalopathy, said Prolira.
UMC Utrecht EEG Department head Frans Leijten said: “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.
“DeltaScan enables clinicians to objectively identify acute encephalopathy, which encompasses delirium, alerting us to act quickly to determine the underlying cause and appropriate interventions.”