MeMed’s Severity Test for Suspected Sepsis Gains FDA Breakthrough Status

MeMed, a developer of advanced host response technologies, has been granted Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration (FDA) for its MeMed Severity test.

The test is intended to advance management of patients with suspected acute infections and suspected sepsis by offering timely, data-driven, clinical insights. It aims to aid clinicians in rapid risk stratification and predicting disease progression, in tandem with clinical assessments and laboratory findings.

The Severity test is based on advanced host-response technology that measures multiple proteins from a blood sample and leverages machine learning to stratify the risk of a patient with suspected acute infection deteriorating to severe outcomes within 72 hours or death within 14 days. It’s designed for emergency department settings and can support critical decision on triage, treatment, and optimized patient disposition.

MeMed says the test generates easy-to-interpret results in under 15 minutes. It’s compatible with high-throughput analyzers and has minimal blood volume requirements.

Beat Müller, M.D., Professor of Medicine at University of Basel said conventional tools of clinical routine—even in top-class hospital centers—often lack predictive accuracy, contributing to alarm fatigue while missing subtle, life-threatening cases.

The FDA’s BDD for MeMed Severity underscores the need for innovative prognostic technologies that not only assess the present but also predict deterioration, enabling timely and informed care decisions,” Dr. Müller told the press. “With rapid results and seamless workflow integration, such advancements have the potential to transform sepsis management and significantly improve patient outcomes.”

“Our vision is to revolutionize diagnostics and improve patient outcomes globally,” added MeMed co-founder and CEO Eran Eden, Ph.D. “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.”