|Chembio Diagnostics Inc., of Medford, N.Y.||DPP Zika IgM System||Includes the DPP Zika IgM assay and DPP Micro Reader; uses a 10 uL fingerstick blood sample; provides results in about 15 minutes||Presumptive qualitative detection of Zika virus IgM antibodies in human serum, potassium-EDTA plasma, potassium-EDTA venous whole blood, or fingerstick whole blood specimens||Received U.S. FDA 510(k) clearance|
|Edwards Lifesciences Corp., of Irvine, Calif.||Sapien 3||Transcatheter heart valve||Treats patients suffering from severe, symptomatic aortic stenosis at high risk for or unable to undergo open-heart surgery||Received Chinese regulatory approval|
|Genetron Holdings Ltd., of Beijing||Genetron SARS-CoV-2 RNA Test||Uses the One-Step Seq Method, which integrates reverse transcription of viral RNA and quantitative PCR reaction in a single step; detects the ORF1ab and N gene sequences of SARS-CoV-2||Qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (such as oropharyngeal, nasopharyngeal, anterior nasal and mid-turbinate nasal swab specimens)||Received emergency use authorization from the U.S. FDA|
|Laminate Medical Technologies Ltd., of Tel Aviv, Israel||Vasq External Support||Implanted blood vessel support device||For the creation of arteriovenous fistulas in hemodialysis patients||Received breakthrough device designation from the U.S. FDA|
|Nuvaira Inc., of Minneapolis||Nuvaira Lung Denervation System||Bronchoscopic procedure with targeted lung denervation||Reduces the risk of moderate-to-severe COPD exacerbations||Received breakthrough device designation from the U.S. FDA|
|Orasure Technologies Inc., of Bethlehem, Pa.||Oragene•Dx (OGD-510) collection kit||At-home saliva collection device for use with Phosphorus SARS-CoV-2 test||Allows individuals who are suspected of being infected with COVID-19 by a health care professional to self-collect saliva specimens||Received emergency use authorization from the U.S. FDA|
|Surmodics Inc., of Eden Prairie, Minn.||Surveil||Drug-coated balloon||Treats peripheral artery disease||Received the CE mark|
For more information about individual companies and/or products, see Cortellis.