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