FRIDAY, March 20, 2026 (NewsDay News) — The US Food and Drug Administration has granted Breakthrough Device designation to MeMed BV Flex, a blood test that differentiates between bacterial and viral infections.
Christie K. Trimm, DO, of TrustCare Health, said in a statement: “This is an innovative type of diagnosis in healthcare.” “A test that differentiates between bacterial and viral infections using the body’s immune response and AI can help clinicians make more informed decisions, reduce unnecessary antibiotic use, prevent bacterial infections, and ultimately improve patient outcomes.”
The test device uses a few drops of capillary blood to measure multiple immune proteins and uses machine learning algorithms to generate a clinical score in 15 minutes. The MeMed Key platform is pending regulatory approval for use in hospitals and clinical laboratory improvement reforms – decentralized care settings.
Eran Eden, Ph.D., CEO and co-founder of MeMed, said in a statement: “We are grateful for the breakthrough device designation from the FDA, which recognizes the strength of our platform technology and helps facilitate our path toward clearing, reimbursement and ultimately advancing the management of patients with fever and sepsis.” “It also validates our core technology with applications beyond infectious diseases.”
MeMed was given the name of the advanced device BV Flex.
