Company Product Description Indication Status
Color Genomics Inc., of Burlingame, Calif. Color SARS CoV-2 LAMP Diagnostic assay Molecular diagnostic for unmonitored testing For the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs, anterior nares swabs, mid-turbinate nasal swabs, nasopharyngeal wash/aspirate or nasal aspirates, as well as bronchoalveolar lavage specimens Received emergency use authorization from the U.S. FDA for at-home collection
Laboratory Corp. of America Holdings (Labcorp), of Burlington, N.C. Labcorp COVID-19 RT-PCR test Molecular diagnostic For the detection of nucleic acid from SARS-CoV-2 Received emergency use authorization from the U.S. FDA for COVID-19 sample pooling and to allow testing in people who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 infection
Rapid Medical Ltd., of Yokneam, Israel Tigertriever Xl Adjustable, fully visible clot retrievers Treats ischemic stroke Received the CE mark
Stratus Medical LLC, of Salt Lake City Vesta RF Cannula Consists of an insulated cannula with an active tip for use in creating a radio frequency (RF) heat lesion for the relief of pain Treatment of chronic pain Received 510(k) clearance from the U.S. FDA
Zebra Medical Vision Inc., of Shefayim, Israel Healthmammo Automatic artificial intelligence tool that analyzes mammograms Assists radiologists by identifying suspicious mammograms to detect breast cancer 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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