Company Product Description Indication Status
Abbott Laboratories, of Abbott Park, Ill. SARS-CoV-2 IgG assay Lab-based serology blood test Qualitative detection of IgG antibodies to SARS-CoV-2 in human serum (including collected using a serum separator tube), and plasma (ACD, CPD, CPDA-1, dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin in a separator tube, sodium citrate, or sodium heparin) Received emergency use authorization from the U.S. FDA for use on the the Alinity I system
Aspenstate Inc., of Plano, Texas Airtouch Portable X-ray system; images are wirelessly transmited to PACS via the onboard workstation For the acquisition of X-ray images for diagnostic procedures Received clearance from the U.S. FDA
Myriad Genetics Inc., of Salt Lake City Mychoice Cdx Companion diagnostic; comprises tumor sequencing of the BRCA1 and BRCA2 genes Identifies advanced ovarian cancer patients with positive homologous recombination deficiency status, who are eligible or may become eligible, for first-line maintenance treatment with Lynparza (olaparib, Astrazeneca) in combination with bevacizuma Received U.S. FDA approval
Elemaster S.p.A. Tecnologie Elettroniche, of Lomagna, Italy Mechanical
Ventilator Milano
Pressure-regulated
mechanical ventilator
Designed for adult patients to provide emergency
ventilation support for intensive therapy during the COVID-19 pandemic
Received emergency use authorization from the U.S. FDA
Visioncare Inc., of Saratoga, Calif. Tsert-Si Delivery system for the Centrasight treatment program; includes a preloaded telescope implant injector For people 65 years and older diagnosed with end-stage, age-related macular degeneration who meet specific eye health and vision requirements, and for whom common treatments such as glasses, vitamins, drugs or cataract surgery will not lead to vision improvement Received the CE mark

Notes

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

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