|Biosensors International Group Ltd., of Singapore||Biofreedom Ultra||Biolimus A9 coated cobalt chromium coronary stent system||For percutaneous coronary intervention procedures in high bleeding risk patients||Received CE mark approval|
|Centogene NV, of Rostock, Germany||Centosure SARS-CoV-2 RT-PCR assay||Real-time test based on the reverse transcription polymerase chain reaction (RT-PCR)||For the qualitative detection of SARS-CoV-2||Received emergency use authorization from the U.S. FDA|
|DNA Genotek Inc., an Ottawa, Ontario-based subsidiary of Orasure Technologies Inc.||Omnigene·Oral (OM-505, OME-505)||Saliva collection and stabilization device||For the self-collection, transport and laboratory testing of saliva specimens suspected of containing SARS-CoV-2 ribonucleic acid||Received emergency use authorization from the U.S. FDA|
|Dxterity Diagnostics Inc., of Rancho Dominguez, Calif.||Safeworkdx||Saliva-based RT-PCR test||For the qualitative detection of SARS-CoV-2; can be taken unsupervised from home or the workplace||Received emergency use authorization from the U.S. FDA|
|Fresenius Medical Care Holdings Inc., of Waltham, Mass.||Delflex in Biofine||Peritoneal dialysis solution with Biofine bag material||For at-home dialysis in patients with kidney failure||Received U.S. FDA approval|
|Ossio Inc., of Woburn, Mass.||Ossiofiber Compression Screw Portfolio||Comprised of a 4.0 mm-diameter cannulated, headless, partially threaded compression screw in lengths ranging from 26mm to 60mm; implant uses bio-integrative material||For maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis and bone grafts of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization||Received 510(k) clearance from the U.S. FDA|
|Thermo Fisher Scientific Inc., of Waltham, Mass.||Taqpath COVID-19 Combo Kit||Molecular, real-time RT-PCR test||For the qualitative detection of nucleic acid from SARS-CoV-2; authorized for use with the Everlywell COVID19 Test Home Collection Kit for individuals to self-collect nasal swab specimens||Received an expansion of its emergency use authorization from the U.S. FDA to include an additional sample collection method provided by Everlywell|
For more information about individual companies and/or products, see Cortellis.