Archive for February 2017
Immunexpress Receives FDA Clearance for Direct-From-Blood Sepsis Test
Revolutionary diagnostic SeptiCyte™ LAB cleared by FDA for suspected sepsis patients.
Read MoreFDA Clears SeptiCyte™ LAB for Suspected Sepsis Patients
The FDA granted 510(k) clearance to Immunexpress for the use of its SeptiCyte™ LAB as an aid in differentiating infection-positive (sepsis) from infection-negative (systemic inflammatory response syndrome, or SIRS) systemic inflammation in critically ill patients on their first day of intensive care unit admission.
Read MoreFDA clears Immunexpress’ RNA-based, whole-blood sepsis Dx
Immunexpress earned 510(k) clearance for its RNA-based clinical diagnostic that detects sepsis in critically ill patients. The test, which uses whole blood, returns results in a few hours.
Read MoreImmunexpress wins FDA clearance for sepsis tests that could save billions of dollars
Immunexpress has won Food and Drug Administration clearance for a diagnostics test that could save hospitals billions of dollars. The FDA cleared SeptiCyte LAB analysis that tests for sepsis, a life-threatening immune response to infection.
Read MoreRevolutionary Diagnostic SeptiCyte™ LAB Cleared By FDA for Suspected Sepsis Patients
SEATTLE, Feb. 22, 2017 – Immunexpress, Inc., a molecular diagnostic company committed to improving outcomes for suspected sepsis patients and healthcare providers, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the use of SeptiCyte™ LAB as an aid in differentiating infection-positive (sepsis) from infection-negative (SIRS) systemic inflammation…
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