The FDA has granted Breakthrough Device Designation to a sepsis risk assessment test designed to support rapid clinical decisions and improve patient outcomes.
RT’s Three Key Takeaways:
- FDA Grants Breakthrough Device Designation: The FDA has designated a sepsis risk assessment test as a Breakthrough Device, signaling its potential to aid in timely clinical decisions for managing suspected sepsis.
- Focus on Predictive Technology: The test applies machine learning to analyze proteins in blood samples, assisting clinicians in predicting severe outcomes or death in patients with suspected sepsis.
- Expedited Regulatory Pathway: The Breakthrough Device Designation is intended to accelerate the test’s regulatory process and facilitate access for healthcare providers.
MeMed announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its MeMed Severity test for patients with suspected sepsis.
This designation underscores the 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.
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.
[RELATED: $100M Funding to Boost Rollout of FDA-Cleared Sepsis Test]
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.
Need for Predictive Tools in Sepsis Management
The Breakthrough Device Designation accelerates MeMed Severity’s path to market, supporting reimbursement strategies and ensuring that this tool reaches healthcare providers as quickly as possible.
[RELATED: Sepsis Cases Rise 72% Driven by Pandemic]
“Managing patients with suspected sepsis is a race against time, where fast and accurate risk assessment is essential. 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,” says Beat Müller, MD, professor of medicine at the University of Basel, in a release. “The FDA’s [Breakthrough Device Designation] 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.”
MeMed Severity has not been approved for sale by any regulatory authority.
Photo caption: MeMed Severity
Photo credit: MeMed/BusinessWire
