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

—AI-powered host-response test designed to deliver lab-level accuracy from a few drops of capillary blood—

—Breakthrough Device Designation to streamline regulatory review and support a pathway toward broader reimbursement coverage—

ANDOVER, Mass. and HAIFA, Israel, March 11, 2026 /PRNewswire/ -- MeMed, a leader in advanced host-response diagnostics, today 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.

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.

Dr. Kristi K. Trimm, TrustCare Health, said: "This is the kind of diagnostic innovation healthcare has been waiting for. A test that distinguishes between bacterial and viral infections using the body's immune response and AI can help clinicians make more confident decisions, reduce unnecessary antibiotic use, avoid missed bacterial infections and ultimately improve patient outcomes. The added flexibility of capillary sampling and CLIA waived status, once granted, could extend that value beyond hospital systems into urgent care and other frontline settings, helping elevate the standard of care across the healthcare continuum."

Eran Eden, Ph.D., CEO and Co-Founder of MeMed, said: "We are grateful for the FDA's Breakthrough Device Designation, which recognizes the strength of our platform technology and helps streamline our path toward clearance, reimbursement, and ultimately advancing the management of patients with fever and sepsis. It also validates our core technology with applications extending well beyond infectious diseases. Together with our current and future partners, our unique ability to integrate machine learning with multiplex host-protein measurements from just a few minimally invasive drops of blood opens a broad range of possibilities across neurology, cardiology, autoimmunity, and other immune-mediated conditions."

*MeMed BV Flex™ is an investigational device and has not been approved or cleared for sale by any regulatory authority.

About MeMed

At MeMed, our mission is to translate the immune system's complex signals into simple insights that transform the way diseases are diagnosed and treated, profoundly benefiting patients and society.

MeMed BV® is the first FDA-cleared host-immune response test for accurately distinguishing between bacterial and viral infections in 15 minutes, based the body's immune response.

MeMed Severity™ has received FDA Breakthrough Device Designation as a host-response test designed to predict severe outcomes up to 72 hours and mortality 14 days in advance in patients with acute infections and suspected sepsis. MeMed Severity is not yet cleared for sale in any territory.

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SOURCE MeMed