Dec. 10, 2024—MeMed announced that the FDA has granted breakthrough device designation to its MeMed Severity test. Designed for emergency department settings, MeMed Severity aims to aid clinicians in rapid risk stratification and predicting disease progression when used in conjunction with clinical assessments and other laboratory findings. The test is based on advanced host-response technology that measures multiple proteins from a blood sample and uses machine learning to stratify the risk of a patient with a suspected acute infection deteriorating to severe outcomes within 72 hours or death within 14 days. It is compatible with high-throughput analyzers, has minimal blood volume requirements, and provides results in less than 15 minutes.