MeMed BV Flex receives FDA Breakthrough Device Designation for rapid infection differentiation
MeMed BV Flex, a rapid capillary blood test utilizing immune response analysis, has been granted FDA Breakthrough Device Designation, promising quick differentiation between bacterial and viral infections in various healthcare environments.
MeMed announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) to MeMed BV Flex, a test designed to accurately distinguish between bacterial and viral infections based on the body’s immune response.
Using just a few drops of capillary blood, the test measures multiple immune proteins and applies machine-learning algorithms to generate a clinically actionable score in 15 minutes. Running on the MeMed Key platform, it is designed for simplicity and intended, pending regulatory clearance, for use across hospitals as well as CLIA-waived and decentralized care settings.
*MeMed BV Flex is an investigational device and has not been approved or cleared for sale by any regulatory authority.
