FDA Grants Breakthrough Device Designation to MeMed BV Flex™ Capillary Blood Test

MeMed has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) to its BV Flex™ test, designed to accurately distinguish between bacterial and viral infections using the body’s immune response.

The test requires only a few drops of capillary blood and measures multiple immune proteins, applying machine-learning algorithms to provide a clinically actionable result in around 15 minutes. 

Running on the MeMed Key™ platform, it is designed for simplicity and, pending regulatory clearance, could be used in hospitals as well as CLIA-waived and decentralized care settings.

By combining capillary sampling with laboratory-level analytical performance, BV Flex™ improves accessibility, particularly for children and the elderly, while delivering accuracy comparable to central laboratory tests. 

The Breakthrough Device Designation is reserved for technologies addressing serious or life-threatening conditions that have the potential to significantly improve standard care. 

It provides priority FDA engagement, accelerating development and review, and may support broader Medicare coverage through programs such as the New Technology Add-on Payment (NTAP) and Transitional Coverage for Emerging Technologies (TCET).

BV Flex™ represents an advance in host-response diagnostics, enabling faster and more confident clinical decision-making, reducing unnecessary antibiotic use, and potentially improving patient outcomes across hospital and frontline care settings.