MeMed has received Breakthrough Device designation for its MeMed Severity sepsis test from the US Food and Drug Administration (FDA).
MeMed’s test is designed to advance the management of individuals with suspected acute infections and sepsis. MeMed says the test helps empower clinicians with timely, data-driven clinical insights, allowing for rapid risk stratification and predicting disease progression, along with clinical assessments and other laboratory findings.
The test builds upon the MeMed BV test, which received FDA clearance in July 2023 and a CE marking under the European In Vitro Diagnostic Devices Regulation (IVDR) in the European Union (EU). It’s the first FDA-cleared host-immune response assay for accurately distinguishing between bacterial and viral infections in just 15 minutes.
MeMed’s new Severity sepsis test also leverages advanced immunoassay technology to analyze specific host-response proteins to provide rapid, reliable results. However, unlike its predecessor, it not only differentiates between bacterial and viral infections, but it can also assess the severity of a patient’s condition. This allows clinicians to make more informed decisions about treatment and resource allocation.
Sepsis remains a pressing global health challenge, with around 49 million cases and 11 million deaths reported annually, representing 20 percent of all global deaths.
In the US, sepsis is a leading cause of death in hospitals and accounts for substantial healthcare costs. The ability to quickly and accurately diagnose sepsis could not only save lives but also reduce the burden on healthcare systems.
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The MeMed Severity sepsis test measures multiple proteins from a blood sample and applies machine learning algorithms to predict the risk of a patient with a suspected acute infection progressing to severe outcomes within 72 hours or death within 14 days.
Specifically designed for emergency department use, it supports critical decisions related to triage, treatment and patient disposition. For example, MeMed says it can help clinicians identify patients who may need escalated care and those who could be safely discharged, optimizing resource allocation and improving patient outcomes.
With results that are easy to interpret in under 15 minutes, compatibility with high-throughput analyzers and minimal blood volume requirements, MeMed Severity seamlessly integrates into clinical workflows, says MeMed. This enhances efficiency and delivers value to both healthcare providers and patients.
The Breakthrough Device designation accelerates MeMed Severity’s journey to market, facilitating reimbursement strategies and ensuring that this essential diagnostic tool reaches healthcare providers as swiftly as possible.
In a statement from MeMed announcing the Breakthrough Device designation for the test, Eran Eden, PhD, CEO and co-founder of MeMed, said, “Our vision is to revolutionize diagnostics and improve patient outcomes globally. The FDA’s Breakthrough Device designation 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 test is currently not approved for sale by any regulatory body.
MeMed says the Breakthrough Device designation accelerates MeMed Severity’s journey to market and also facilitates reimbursement strategies, “ensuring that this critical tool reaches healthcare providers as quickly as possible.”
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