MeMed today announced that the FDA has granted Breakthrough Device Designation (BDD) to its MeMed Severity test. This designation underscores the potential of MeMed Severity to advance the management of patients with suspected acute infections and suspected sepsis.
Building on the scaling adoption of the FDA-cleared MeMed BV test, 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 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. The BDD accelerates MeMed Severity's path to market, supporting reimbursement strategies, and ensuring that this critical tool reaches healthcare providers as quickly as possible.
