🗞 Medical Articles
Topic: FDA clears first in-class test for rapid sepsis diagnosis
Inflammatix received FDA clearance for its TriVerity Test System, a first-in-class molecular test designed to rapidly diagnose bacterial and viral infections and assess illness severity in patients with suspected acute infections or sepsis. FDA's decision was based on the SEPSIS-SHIELD study, which demonstrated high diagnostic and prognostic accuracy in 1,222 patients across 22 sites, regardless of immune status or race.
Link: https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241676.pdf
@HakimApps_Guideline
Source: FDA
Topic: FDA clears first in-class test for rapid sepsis diagnosis
Inflammatix received FDA clearance for its TriVerity Test System, a first-in-class molecular test designed to rapidly diagnose bacterial and viral infections and assess illness severity in patients with suspected acute infections or sepsis. FDA's decision was based on the SEPSIS-SHIELD study, which demonstrated high diagnostic and prognostic accuracy in 1,222 patients across 22 sites, regardless of immune status or race.
Link: https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241676.pdf
@HakimApps_Guideline