×
ADVERTISEMENT

JANUARY 17, 2025

FDA Grants Breakthrough Device Designation to New Sepsis Test


Originally published by our sister publication Infectious Disease Special Edition

By IDSE News Staff

The FDA has granted Breakthrough Device designation to a new rapid diagnostic blood test for sepsis (MeMed Severity, MeMed).

Built for use in emergency departments, the test uses host response technology to measure multiple proteins in a blood sample and then risk-stratifies patients using a machine learning algorithm. The test, which produces results in less than 15 minutes, can signify whether a