Company Product Description Indication Status
Biohit Healthcare (Hefei) Co. Ltd., of Hefei, China Biohit SARS-CoV-2 IgM/IgG antibody test Rapid laminar flow assay Detects IgG and IgM antibodies to SARS-CoV-2 Received ANVISA status from Brazil's Ministry of Health
Biohit Healthcare (Hefei) Co. Ltd., of Hefei, China Biohit SARS-CoV-2 Antigen quantitative assay kit Enzyme-linked immunoassay Shows who has or does not have active COVID-19 Received ANVISA status from Brazil's Ministry of Health
Cardiac Dimensions Pty. Ltd., of Sydney Carillon Mitral Contour system Right heart transcatheter mitral valve repair device Treatment of functional mitral regurgitation Received approval from Australia's Therapeutic Goods Administration
Detectachem Inc., of Stafford, Texas Mobiledetect Bio BCC19 test kit Testing solution that uses a reverse transcription loop-mediated isothermal nucleic acid amplification technique; compatible with mobile app for real-time results analysis and reporting For the qualitative detection of RNA from SARS-CoV-2 in
nasopharyngeal, anterior nasal swabs, mid-turbinate nasal swabs, and oropharyngeal swab specimens
Received emergency use authorization from the U.S. FDA
Exsomed Corp., of Aliso Viejo, Calif. Inframe Intramedullary Micro Nail Threaded micro nail For proximal phalanx fracture surgeries Received 510(k) clearance from the U.S. FDA
Pq Bypass Inc., of Milpitas, Calif. Detour system Femoral-popliteal bypass device To treat extremely long, complex blockages in the superficial femoral artery Received breakthrough device designation
Tissue Regeneration Technologies LLC, of Woodstock, Ga. Orthogold 100 Unfocused extracorporeal shock wave device Treatment of superficial, partial-thickness, second-degree burns in adults Received 510(k) clearance from the U.S. FDA

Notes

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