April 2026—The FDA has granted breakthrough device designation to MeMed’s BV Flex, a blood test designed to distinguish between bacterial and viral infections based on the body’s immune response. Using 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. BV Flex runs on the MeMed Key platform and is intended, pending regulatory clearance, for use in hospitals as well as CLIA-waived and decentralized care settings.
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