Fierce Biotech April 5, 2024
The diagnostics startup Prenosis has scored a groundbreaking green light from the FDA for an artificial intelligence-powered tool that aims to spot the early signs of sepsis.
The agency’s de novo clearance for the Chicago-based company’s ImmunoScore software allows it to help predict cases where the body’s immune system may severely overreact to an infection and cause damage to healthy organs and tissues.
The AI assessment aid takes in 22 different biomarkers and pieces of clinical data and assigns a patient to one of four risk levels, linked to the possibility of or progression to sepsis within 24 hours of being checked out in a hospital or emergency room.
The system itself does not provide alerts to clinicians; instead,...