The U.S. Food and Drug Administration (FDA) has granted marketing authorization to artificial intelligence (AI) healthcare firm Prenosis' AI-based ImmunoScore sepsis risk-assessment software last week, using the de novo pathway.
ImmunoScore uses data from the patient's electronic health record in conjunction with clinical assessments and laboratory findings to assist healthcare providers in assessing the risk of sepsis development or progression in a patient within 24 hours of assessment.
"FDA authorization of a sepsis diagnostic tool with significant predictive power is a landmark event for people that could ever be at risk of sepsis at some point in their lives," Prenosis' co-founder and CEO Bobby Reddy, Jr, PhD, said in a statement. "Until now, there was no other FDA authorized AI diagnostic for sepsis, which is why the Sepsis ImmunoScore had to be granted marketing authorization through the De Novo pathway. FDA authorization offers yet another important piece of evidence of the potential of the Sepsis ImmunoScore to improve care."
ImmunoScore was developed with the firm's Immunix platform, which was used to build a proprietary biobank and dataset of more than 100,000 blood samples from over 25,000 patients.
According to the U.S. Centers for Disease Control and Prevention, at least 1.7 million adults in the U.S. develop sepsis each year; nearly 270,000 die.
"Sepsis is a serious and sometimes deadly complication. Technologies developed to help prevent this condition have the potential to provide a significant benefit to patients," Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in an FDA statement. "To help ensure the safety and effectiveness of software as a medical device, the FDA's authorization of the Prenosis Sepsis ImmunoScore software establishes specific premarket and postmarket requirements for this device type, including software validation and clinical performance testing for the intended use before they are authorized for marketing."
