BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Respiratory Viral Panel (RVP) for BD MAX™ System, a single molecular diagnostic combination test that identifies and distinguishes SARS-CoV-2, influenza A, influenza B, and Respiratory Syncytial Virus (RSV) in approximately two hours.

Meridian Bioscience said on Tuesday that it has received US Food and Drug Administration clearance for its Premier HpSA Flex assay for the diagnosis of Helicobacter pylori in both preserved and unpreserved stools.

Invivoscribe is excited to announce that the LeukoStrat CDx FLT3 Mutation Assay has been approved by the U.S. Food and Drug Administration (FDA) to aid in the selection of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) who may be eligible to receive treatment with Daiichi Sankyo’s VANFLYTA® (quizartinib).

Siemens Healthineers said Thursday that it has received US Food and Drug Administration clearance for an analyzer designed for immunoassay and clinical chemistry testing in low- to medium-volume laboratories.

The US Food and Drug Administration (FDA) has granted approval for Lumos Diagnostics’ FebriDx rapid point-of-care (POC) test.

Renalytix has received De Novo marketing authorisation from the US Food and Drug Administration (FDA) for its KidneyIntelX.dkd prognostic test.

LumiraDx Limited (Nasdaq: LMDX), a leading innovator in diagnostic technologies, today announced the submission of its first 510(k) application to the U.S. Food and Drug Administration (FDA) for the clearance of its ground-breaking 5-minute COVID Ultra Test. LumiraDx submitted a traditional 510(k) Dual Submission for LumiraDx SARS-CoV-2 Ag Ultra with CLIA Waiver for the commercial distribution at point of care of the LumiraDx Platform, including the LumiraDx Instrument, with the LumiraDx SARS-CoV-2 Antigen (Ag) Ultra test, and the LumiraDx SARS-CoV-2 Ag Quality Control Swab Kit.

ARUP Laboratories today announced that the U.S. Food and Drug Administration (FDA) has approved AAV5 DetectCDx™ as a companion diagnostic to aid in the selection of adult patients eligible for treatment with ROCTAVIAN™ (valoctocogene roxaparvovec-rvox).

Roche said Tuesday that it secured US Food and Drug Administration 510(k) clearances for a pair of assays to aid diagnosis of Alzheimer's disease measuring levels of beta-amyloid and tau proteins.

The US Food and Drug Administration announced on Tuesday that it has launched a voluntary pilot program intended to reduce the risks of laboratory-developed tests used to select patients for oncology therapies.