Company Product Description Indication Status
Archerdx Inc., of Boulder, Colo. Next-generation sequencing device Companion diagnostic Detects neurotrophic receptor tyrosine kinase gene fusions that lead to the formation and growth of cancer Received a breakthrough device designation from the U.S. FDA
Bio-Rad Laboratories Inc., of Hercules, Calif. CFX96 Dx Real-Time PCR system Molecular diagnostic instrument To help in the diagnosis of COVID-19 Listed with the U.S. FDA for IVD testing
Cochlear Ltd., of Sydney Cochlear Nucleus implants Cochlear implant For children with bilateral, profound sensorineural hearing loss. U.S. FDA expanded age of cochlear implantation from 12 months to 9 months
Invivoscribe Inc., of San Diego Leukostrat CDx FLT3 mutation assay PCR-based in vitro diagnostic test; for use on the 3500xL Dx Genetic Analyzer Detects internal tandem duplication and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML); used as an aid in the assessment of patients with AML for whom Rydapt (midostaurin) and/or Xospata (gilteritinib) treatment is being considered Received a PMA supplement approval from the U.S. FDA for in-house testing
Ortho Clinical Diagnostics Inc., of Raritan, N.J. Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG test Immunoassay Detects the IgG antibody in patients exposed to SARS-CoV-2 virus Received the CE mark
Quidel Corp., of San Diego Lyra Direct SARS-CoV-2 assay Molecular assay; uses a reformulated buffer that replaces the extraction step For the qualitative detection of nucleic acid from SARS-CoV-2 in nasal, nasopharyngeal, or oropharyngeal, direct swab specimens Received emergency use authorization from the U.S. FDA
Quidel Corp., of San Diego Lyra Direct SARS-CoV-2 assay Molecular assay; uses a reformulated buffer that replaces the extraction step For the qualitative detection of nucleic acid from SARS-CoV-2 in nasal, nasopharyngeal, or oropharyngeal, direct swab specimens Received the CE mark
Theradiag, of Croissy Beaubourg, France, and Mikrogen GmbH, of Neuried, Germany Amplicube Coronavirus SARS-CoV-2 test RT-PCR in vitro test Detects nucleic acid from SARS-CoV-2 on nasopharyngeal swabs Received approval from the National Reference Center of Paris
Thermedical Inc., of Waltham, Mass. Saline Enhanced Radiofrequency (SERF) Ablation system Uses the the Durablate catheter Treats ventricular tachycardia Received a breakthrough device designation from the U.S. FDA

Notes

For more information about individual companies and/or products, see Cortellis.

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