Company Product Description Indication Status
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

Notes

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

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