FDA Provides Breakthrough Device Designation to MeMed BV Flex

By Lori Solomon HealthDay Reporter

Medically reviewed by Drugs.com

via HealthDay

FRIDAY, March 20, 2026 -- The U.S. Food and Drug Administration has granted Breakthrough Device designation to MeMed BV Flex, a blood test that differentiates between bacterial and viral infections.

"This is the kind of diagnostic innovation health care has been waiting for," Kristi K. Trimm, D.O., of TrustCare Health, said in a statement. "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 investigational device uses a few drops of capillary blood to measure multiple immune proteins and applies machine-learning algorithms to generate a clinically actionable score in 15 minutes. Pending regulatory clearance, the MeMed Key platform is intended for use in hospitals and Clinical Laboratory Improvement Amendments-waived, decentralized care settings.

"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," Eran Eden, Ph.D., CEO and cofounder of MeMed, said in a statement. "It also validates our core technology with applications extending well beyond infectious diseases."

Breakthrough Device designation of BV Flex was granted to MeMed.

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Source: HealthDay

Posted : 2026-03-21 08:43

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FDA Provides Breakthrough Device Designation to MeMed BV Flex

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