Thursday, April 04, 2024
Prenosis, a pioneering force in artificial intelligence for precision medicine in acute care, has announced a significant breakthrough: the Sepsis ImmunoScore™ has been granted marketing authorization by the U.S. Food and Drug Administration (FDA) through the De Novo pathway. This achievement is monumental as it marks the first FDA approval for an AI diagnostic tool designed to detect sepsis. Sepsis, known for its intricate nature and challenge in early identification, poses a formidable hurdle for the healthcare system due to its substantial cost and mortality rates.
The Sepsis ImmunoScore™ leverages artificial intelligence and machine learning to swiftly diagnose and predict sepsis within a critical 24-hour window following patient assessment, particularly vital in emergency departments and hospital settings. Analyzing a comprehensive array of 22 parameters, this innovative technology furnishes clinicians with a holistic risk assessment, aiding in anticipating patient deterioration and guiding necessary care escalation.
Seamlessly integrated into hospital Electronic Medical Records, the Sepsis ImmunoScore™ provides clinicians with convenient access to patient data and diagnostic insights. Developed on Prenosis' Immunix™ precision medicine platform, which encompasses a vast dataset of over 100,000 blood samples from more than 25,000 patients, this tool represents a significant stride forward in personalized medicine for acute care.
The FDA's authorization underscores the transformative potential of the Sepsis ImmunoScore™ in enhancing patient care and outcomes, marking a pivotal moment in the advancement of precision medicine within acute care settings.
Source: prnewswire.com
