Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
T2 Biosystems, Vanderbilt University Medical Center Partner on Prospective Bacterial Sepsis Dx Study
The medical center will evaluate whether the T2Bacteria Panel improves antibiotic usage and clinical interventions for sepsis patients.
Acutis Diagnostics Gets FDA Emergency Use Authorization for COVID-19 RT-PCR Test
The test is designed to detect SARS-CoV-2 in nasopharyngeal swab specimens from people suspected of having COVID-19.
FDA Grants Marketing Authorization for Cue Health COVID-19 At-Home Molecular Test
The nucleic acid amplification test is the first at-home, over-the-counter test for COVID-19 to be granted marketing authorization using the traditional premarket review pathway.
Sysmex Gets Approval in Japan for Retinal Dystrophy Gene Panel
The next-generation sequencing panel identifies genetic mutations that cause inherited retinal dystrophy, which results in vision problems, including blindness.
Cepheid Nabs CE-IVD Mark for Molecular NPM1 Mutation Test for AML Monitoring
The test quantifies mutant NPM1 mRNA transcripts in peripheral blood specimens from patients with acute myeloid leukemia.