Overview
MeMed develops host-immune response diagnostics, including the FDA-cleared MeMed BV test that distinguishes bacterial from viral infections in 15 minutes using serum or whole blood on the compact MeMed Key platform. The test measures immune proteins like TRAIL, IP-10, and CRP with machine learning for actionable scores, aiding antibiotic stewardship and reducing antimicrobial resistance. Additional products like MeMed BV Flex (FDA Breakthrough Designation for capillary blood) and MeMed Severity (for predicting severe outcomes) expand point-of-care capabilities in hospitals and decentralized settings.
Frequently asked questions
- What regulatory approvals does MeMed BV have?
- MeMed BV is FDA-cleared and CE-marked for differentiating bacterial from viral infections in 15 minutes from serum or venous whole blood.
- What sample types and platforms does MeMed use?
- MeMed BV uses serum or venous whole blood on the FDA-cleared MeMed Key platform; MeMed BV Flex (investigational) uses capillary blood for point-of-care in hospitals and CLIA-waived settings.
- What clinical validation supports MeMed's tests?
- MeMed BV performance is validated in multinational, double-blind studies and real-world use on nearly 20,000 patients across Europe, Israel, and the US, covering diverse bacterial and viral pathogens.