Originally published by our sister publication Infectious Disease Special Edition
By IDSE News Staff
The FDA has granted Breakthrough Device designation to a new rapid diagnostic blood test for sepsis (MeMed Severity, MeMed).
Built for use in emergency departments, the test uses host response technology to measure multiple proteins in a blood sample and then risk-stratifies patients using a machine learning algorithm. The test, which produces results in less than 15 minutes, can signify whether a patient may be at risk for severe outcomes within 72 hours or death within 14 days, according to a MeMed press release.
The test could help providers triage patients quickly, Beat Müller, MD, a professor of medicine at the University of Basel, in Zurich, said in the statement.
"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. 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."
Although the test is not yet available for purchase, the new designation will expedite its path to market, according to the company, and help in negotiating reimbursement strategies for the test.
Eran Eden, PhD, the CEO and co-founder of MeMed, said: “We’re currently working closely with regulatory authorities to align on requirements. Once that alignment is complete, we’ll have a clear time line to share.”
Based on a MeMed press release.
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