The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to MeMed for its rapid diagnostic and risk assessment test for sepsis.
The MeMed Severity test, which is designed for use in emergency departments, uses host-response technology to measure multiple proteins in a blood sample and a machine-learning algorithm to stratify the risk for patients with infections deteriorating to severe outcomes within 72 hours or death within 14 days, the company said in a statement. The test is compatible with high-throughput analyzers and requires minimal blood volume; results are available in 15 minutes.
While the test has not yet been approved for sale by any regulatory agency, the designation accelerates MeMed Severity’s path to market and supports reimbursement strategies, the company said. MeMed's BV test, which assists healthcare providers in differentiating between bacterial and viral infections, has been granted 510(k) clearance by the FDA and is CE-marked under the In Vitro Diagnostic Medical Devices Regulation in the European Union.
