Company Product Description Indication Status
Abiomed Inc., of Danvers, Mass. Abiomed Breethe Oxy-1 system All-in-one, compact cardiopulmonary bypass system Pumps, oxygenates and removes carbon dioxide from blood during cardiopulmonary bypass for up to 6 hours Received 510(k) clearance from the U.S. FDA
Foldax Inc., of Salt Lake City Tria Biopolymer aortic heart valve For surgical aortic valve replacement The U.S. FDA granted approval to expand enrollment for its clinical study
Foundation Medicine Inc., of Cambridge, Mass. Foundationone Cdx Tissue-based comprehensive genomic profiling test Detects NTRK1/2/3 fusions across all solid tumor types and identifies patients who may be appropriate for treatment with Vitrakvi Received approval from the U.S. FDA to be used as a companion diagnostic for Vitrakvi (larotrectinib, Bayer)
Helix Opco LLC, of San Mateo, Calif. Helix COVID-19 test Real-time RT-PCR test Qualitative detection of nucleic acid from SARS-CoV-2 Received an expanded emergency use authorization from the U.S. FDA to allow on-site unsupervised self-collection and asymptomatic screening
Kantaro Biosciences LLC, of New York, and Bio-Techne Corp., of Minneapolis COVID-Seroklir Quantitative SARS-CoV-2 IgG antibody test kits Detects the presence or absence of COVID-19 antibodies in a clinical setting Received the CE mark
Kantaro Biosciences LLC, of New York, and Bio-Techne Corp., of Minneapolis COVID-Seroindex Quantitative SARS-CoV-2 IgG antibody test kits Detects the presence or absence of COVID-19 antibodies; for use in research purposes or vaccine development Received the CE mark
Perkinelmer Inc., of Waltham, Mass. Pkamp Respiratory SARS-CoV-2 RT-PCR panel Multi-analyte panel designed to test a single sample; for use with Perkinelmer's automated viral nucleic extractor For the detection and differentiation between SARS-CoV-2, influenza A viruses, influenza B viruses and respiratory syncytial virus Received the CE mark
Siemens Healthineers AG, of Erlangen, Germany Ysio X.Pree Ceiling-mounted radiography system with the Myexam Companion intelligent user interface For capturing X-ray images; guides users through exam workflow Received 510(k) clearance from the U.S. FDA
Theranica Bio-Electronics Ltd., of Netanya, Israel Nerivio Smartphone-controlled therapeutic device to be worn on the upper arm; uses remote electrical neuromodulation Treatment of migraine in adults Received expanded clearance from the U.S. FDA to include indication for chronic migraine; previously approved for acute treatment of migraine

Notes

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