Summary: The FDA has granted Breakthrough Device Designation to MeMed Severity, a host-response technology that uses advanced machine learning to predict the risk of severe outcomes in patients with suspected sepsis, enabling timely and informed clinical decisions.
Takeaways:
- Transforming Sepsis Management: MeMed Severity leverages machine learning and host-response technology to rapidly assess the risk of severe outcomes in patients with suspected sepsis, providing results in under 15 minutes to aid critical triage and treatment decisions.
- FDA Breakthrough Device Designation: The FDA’s designation accelerates MeMed Severity’s path to market, recognizing its potential to address critical gaps in sepsis management by enabling clinicians to predict deterioration and optimize patient care.
- Advancing Prognostic Technologies: Designed for emergency department settings, MeMed Severity integrates seamlessly into clinical workflows, offering high-throughput compatibility and actionable insights that aim to reduce alert fatigue and improve outcomes for high-risk patients.
MeMed, a provider in the emerging field of advanced host response technologies, announced that the FDA has granted Breakthrough Device Designation (BDD) to its innovative MeMed Severity test. This designation underscores the transformative potential of MeMed Severity to advance the management of patients with suspected acute infections and suspected sepsis by empowering clinicians with timely, data-driven, clinical insights.
Testing for Acute Infections
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.
About the MeMed Severity Test
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, the company says. 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.
“Managing patients with suspected sepsis is a race against time, where fast and accurate risk assessment is essential,” says Beat Müller, MD, professor of medicine, University of Basel. “Conventional tools of clinical routine even in top-class hospital centers often lack predictive accuracy, contributing to alert 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. With rapid results and seamless workflow integration, such advancements have the potential to transform sepsis management and significantly improve patient outcomes.”
Further Reading
Eran Eden, PhD, CEO and co-founder of MeMed, says: “Our vision is to revolutionize 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.”
MeMed Severity has not been approved for sale by any regulatory authority. The information provided here is for informational purposes only and is not intended to substitute for professional medical advice, diagnosis, or treatment. MeMed BV is FDA-cleared in the United States and CE-marked under the IVDR in the European Union.
