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.

By combining capillary sampling with laboratory-level analytical performance, MeMed BV Flex™ expands accessibility, particularly for children and elderly, while delivering accuracy traditionally limited to central laboratory infrastructure.

Breakthrough Device Designation is reserved for technologies addressing life-threatening or irreversibly debilitating conditions and demonstrating the potential to significantly improve the standard of care. The designation provides prioritized and more interactive FDA engagement, accelerating development and regulatory review. In addition, BDD provides eligibility to Medicare’s New Technology Add-on Payment (NTAP) alternative pathway and Transitional Coverage for Emerging Technologies (TCET). These programs may support broader Medicare coverage, strengthening market access and commercial readiness.