Company Product Description Indication Status
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

Notes

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

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