MeMed Receives FDA Approval to MeMed BV Flex™ Breakthrough Device Designation for Capillary Blood Test
MeMed has been granted Breakthrough Device Designation (BDD) by the U.S. Food and Drug Administration for its MeMed BV Flex™ diagnostic test.
This recognition highlights the potential of the technology to address an important clinical need.
The MeMed BV Flex™ test is designed to differentiate between bacterial and viral infections by evaluating the body’s immune response.
It requires only a small sample of capillary blood and measures several immune-related proteins. Using machine-learning algorithms, the system delivers results that can support clinical decision-making in approximately 15 minutes.
The test operates on the MeMed Key™ platform and is intended—subject to regulatory clearance—for use in hospitals as well as in decentralized and CLIA-waived care settings.
By combining the convenience of capillary blood collection with the accuracy typically associated with laboratory testing, the platform may be especially beneficial for patients such as children and older adults who can find traditional blood draws difficult.
Receiving BDD status allows for closer interaction with the FDA, which may accelerate both development and the review process. It can also help pave the way for expanded Medicare coverage in the future.
Overall, MeMed BV Flex™ aims to enable faster and more precise identification of infection types, helping clinicians make informed treatment decisions, limit unnecessary antibiotic use, and improve patient outcomes across a range of healthcare environments.
