Company Product Description Indication Status
Canon Medical Systems USA Inc., of Tustin, Calif. Aquilion Exceed LB Large bore CT system with Advanced Intelligent Clear-IQ Engine deep learning reconstruction technology For acquiring and displaying cross-sectional volumes of the whole body, to include the head; supports radiation oncology workflows Received 510(k) clearance from the U.S. FDA
Covaxx, a Hauppauge, N.Y.-based subsidiary of United Biomedical Inc. (UBI) UBI SARS-CoV-2 ELISA Enzyme-linked immunosorbent assay (ELISA) antibody blood diagnostic test For the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma from individuals that are 15 days or more post-symptom onset Received emergency use authorization from the U.S. FDA
Lumiradx UK Ltd., of London Lumiradx SARS-CoV-2 Antigen Test Microfluidic immunofluorescence assay Detects SARS-CoV-2 antigen in nasal or nasopharyngeal swab specimens Received approval from Japan's Pharmaceutical and Medical Devices Agency
Lumiradx UK Ltd., of London Lumiradx SARS-CoV-2 Antigen Test Microfluidic immunofluorescence assay Detects SARS-CoV-2 antigen in nasal or nasopharyngeal swab specimens The Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária) issued approval
Retia Medical LLC, of Valhalla, N.Y. Argos Cardiac output monitor with Multi-Beat Analysis algorithm For hemodynamic monitoring Received CE mark approval
Zimmer Biomet Holdings Inc., Warsaw, Ind., and Bactiguard Holding AB, of Tullinge, Sweden Bactiguard-coated Zimmer Biomet trauma implants Orthopedic implant with coating to prevent infection Restores anatomic shape to fractured bones Obtained the CE mark

Notes

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