respiratory infection
BioMérieux Point-of-Care System, Respiratory Panel Get FDA 510(k) Clearance, CLIA Waiver
The BioMérieux BioFire Spotfire Respiratory Panel was reviewed through the FDA's dual 510(k)/CLIA waiver pathway, making it the first COVID-19 test to be cleared with a CLIA waiver.
At the AMP annual meeting this week, the company outlined its technology and vision for a speedy, low-cost, high-accuracy diagnostic.
Curetis to Assist BioVersys' Antibacterial Drug Trial With Unyvero Platform
BioVersys will use the Unyvero HPN in its drug trial to test hospitalized trial candidates for antibiotic-resistant Acinetobacter infections.
The company expects the trial results to bolster sales by increasing physician confidence in the panel.
Luminex Obtains CE Marking for MDx Panel to Detect Flu A/B, RSV, COVID-19
Results are generated in a single workflow from a patient sample, which enables rapid detection for the differential diagnosis of a single pathogen.