Company Product Description Indication Status
Behold.ai Technologies Ltd., of London Red dot Artificial intelligence algorithm For radiology triage; alerts radiologists of collapsed lung (pneumothorax) as soon as chest X-ray image is captured Received CE mark approval
Chembio Diagnostic Systems Inc., of Medford, N.Y. DPP COVID-19 IgM/IgG system Serological, point-of-care test that provides results within 15 minutes; for use on Chembio's Micro Reader 1 and Micro Reader 2 analyzers Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in serum, plasma (EDTA or lithium heparin), venous whole blood, or fingerstick whole blood; for use by CLIA-certified laboratories Received emergency use authorization from the U.S. FDA
Nova Biomedical Corp., of Waltham, Mass. Stat Profile Prime Plus analyzer system Includes blood gas analyzer and sensor cartridges For quantitative determination of
hematocrit, oxygen saturation, total hemoglobin, oxyhemoglobin, carboxyhemoglobin,
methemoglobin, and deoxyhemoglobin in heparinized arterial and venous whole blood
Received expanded 510(k) clearance from the U.S. FDA for point-of-care use
Ortho Clinical Diagnostics Inc., of Raritan, N.J. Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack Serology total antibody test; runs on the Vitros XT 7600 integrated system, Vitros 3600 immunodiagnostic system and Vitros 5600 integrated system Qualitative detection of total antibodies (including IgG and IgM) to SARS-CoV-2 in human serum and plasma (K2 EDTA) specimens; for use by CLIA-certified laboratories Received emergency use authorization from the U.S. FDA

Notes

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

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