MeMed announced that the Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) to its innovative MeMed Severity test.
Building on the scaling adoption of the FDA-cleared MeMed BV test, which redefines how clinicians differentiate between bacterial and viral infections, MeMed Severity aims to aid clinicians in rapid risk stratification and predicting disease progression, 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. Designed for emergency department settings, it has the potential to support critical decisions on triage, treatment, and optimized patient disposition – for example, assisting clinicians in identifying who could benefit from escalated care and who might be safely discharged from the hospital.
With easy-to-interpret results in under 15 minutes, compatibility with high-throughput analyzers and minimal blood volume requirements, MeMed Severity will integrate into clinical workflows, driving value for both care providers and patients.
