MeMed has received breakthrough device designation (BDD) from the US Food and Drug Administration (FDA) for its MeMed Severity test, designed to enhance the management of patients with suspected acute infections and sepsis.
The test leverages host-response technology to measure proteins in blood samples. It employs machine learning to stratify patients' risk of severe outcomes or death within a specified timeframe.
Its capability for rapid risk stratification and prediction of disease progression complements clinical assessments and other laboratory findings.
MeMed Severity builds upon the FDA-cleared MeMed BV test, which assists clinicians in distinguishing between bacterial and viral infections.
It is tailored for emergency department use, supporting critical decisions on patient triage, treatment, and disposition. It assists clinicians in determining which patients require escalated care and who can be safely discharged.
With results available in less than 15 minutes, the test's compatibility with high-throughput analysers, quick results, and minimal blood volume requirements are designed to seamlessly integrate into existing clinical workflows.
MeMed CEO and co-founder Eran Eden said: "Our vision is to revolutionise diagnostics and improve patient outcomes globally.
“The FDA’s BDD for MeMed Severity validates our commitment to addressing critical healthcare challenges with novel host-response technologies.
“We are grateful for the FDA’s commitment to collaborate with MeMed during its rigorous development process to create a test capable of filling a critical gap in sepsis management, equipping clinicians with valuable insights to improve care and save lives."
The designation not only expedites the test's market introduction but also aids in establishing reimbursement strategies.
MeMed Severity has not received approval for sale by any regulatory authority.
In July 2023, MeMed BV was cleared by the FDA in the US and received a CE marking under the European In Vitro Diagnostic Devices Regulation (IVDR) in the EU.
