MeMed Severity Test Nabs Breakthrough Device DesignationMeMed Severity Test Nabs Breakthrough Device Designation

MeMed, a medtech company focused on translating the immune system’s complex signals into simple insights that transform how diseases are diagnosed and treated, today announced that FDA has granted Breakthrough Device Designation (BDD) to its MeMed Severity test. The test aims to advance the management of patients with suspected acute infections and suspected sepsis through timely, data-driven clinical insights.

Based on advanced host-responsive technology, the test measures multiple proteins from a blood sample and, through machine learning, calculates the risk of a suspected acute infection patient deteriorating to severe outcomes within 72 hours or death within 14 days. The device builds on the FDA-cleared MeMed BV test that helps clinicians differentiate between bacterial and viral infections, with the new device instead aiding in the rapid risk stratification and prediction of disease progression in partnership with clinical assessment and additional laboratory findings.

With results available in under 15 minutes and compatibility with high-throughput analyzers and minimal blood volume needs, MeMed Severity, the company said, has the potential to optimize and support critical decisions on patient triage, treatment, and disposition, “for example, assisting clinicians in identifying who could benefit from escalated care and who might be safely discharged from the hospital,” according to the press release.

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Now with FDA’s BDD stamp, MeMed can accelerate the device’s path to market, which will support reimbursement strategies. "Our vision is to revolutionize diagnostics and improve patient outcomes globally,” said Eran Eden, PhD, CEO and co-founder of MeMed. “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."