FDA Clearance
In Fight Against AMR, FDA Grants Second Clearance to Selux’s Next Generation Phenotyping System
The FDA has granted a second 510(k) clearance to the Selux Next Generation Phenotyping (NGP) System (Selux ...
APRIL 26, 2023
FDA Clears Cytovale’s IntelliSep Sepsis Test
The FDA cleared the IntelliSep (Cytovale) test to improve the early detection of sepsis in the approximately 30 ...
JANUARY 24, 2023
FDA Clears Selux’s Next-Gen Phenotyping System
The FDA granted 510(k) clearance to the Next Generation Phenotyping System (Selux Diagnostics), a rapid antibiotic ...
JANUARY 19, 2023
FDA Clears VIDAS NephroCheck for Detection of Kidney Stress in AKI Patients
The FDA granted clearance to bioMérieux for the innovative VIDAS NephroCheck test to detect kidney stress in ...
JULY 29, 2022
FDA Grants Breakthrough Device Designation for the T2Resistance Panel
New, expanded panel detects gram-negative and -positive resistance genes to help combat antibiotic-resistant ...
FEBRUARY 28, 2019
FDA Clears First Test for Detecting CMV in Newborns
CMV is the most common congenital infection and a leading cause of childhood cognitive deficits, hearing loss and ...
DECEMBER 11, 2018
FDA Clears Quidel Point-of-Care Lyme Disease FIA
The FDA gives the nod to Quidel's Sofia 2 Lyme Fluorescent Immunoassay (FIA), a point-of-care diagnostic test.
SEPTEMBER 5, 2018
FDA Clears T2Bacteria Panel for Detecting Sepsis-Causing Pathogens
Sepsis affects 1.6 million U.S. patients each year, resulting in more than 250,000 deaths.
JUNE 2, 2018
FDA Clears First Test for C. auris
The Biotyper CA system uses a technology known as matrix-assisted laser desorption/ionization time-of-flight mass ...
APRIL 23, 2018
FDA Clears Unyvero System, Unyvero LRT Test
The FDA has cleared the Unyvero System and Lower Respiratory Tract Infection Application Cartridge from ...
APRIL 4, 2018
