|1drop Inc., of Seongnam, South Korea||1copy COVID-19 qPCR Multi Kit||Molecular test||For the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, oropharyngeal, anterior nasal, mid-turbinate nasal swab specimens as well as nasopharyngeal wash/aspirates and nasal aspirate specimens||Received emergency use authorization from the U.S. FDA|
|Agilent Technologies Inc., of Santa Clara, Calif.||PD-L1 IHC 28-8 pharmDx||Qualitative immunohistochemical assay using Monoclonal Rabbit Anti-PD-L1, Clone 28-8||Aids in identifying patients with metastatic non-small-cell lung cancer for treatment with the dual immunotherapy combination of Opdivo (nivolumab) and Yervoy (ipilimumab), manufactured by Bristol Myers Squibb||Received expanded U.S. FDA approval for use as a companion diagnostic|
|Edwards Lifesciences Corp., of Irvine, Calfi.||Pascal||Transcatheter valve repair system||Treatment for tricuspid regurgitation||Received the CE mark|
|Everlywell Inc., of Austin, Texas||COVID-19 Test Home Collection Kit||Contains nasal swabs to collect a sample and a tube filled with saline||Allows an individual to self-collect a nasal sample at home; for use with diagnostic tests performed by Fulgent Therapeutics and Assurance Scientific Laboratories||Received emergency use authorization from the U.S. FDA|
|Fulgent Genetics Inc., of Temple City, Calif.||Fulgent COVID-19 by RT-PCR Test||Molecular test||For the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (nasal, nasopharyngeal, and oropharyngeal swabs)||Received emergency use authorization from the U.S. FDA|
|Zebra Medical Vision Ltd., of Shefayim, Israel||Vertebral Compression Fractures||Artificial intelligence software; automatically identifies findings suggestive of compression fractures||Aids clinicians in identifying patients that are at risk of osteoporosis||Received 510(k) clearance from the U.S. FDA|
For more information about individual companies and/or products, see Cortellis.