Company Product Description Indication Status
Becton, Dickinson and Co. (BD), of Franklin Lakes, N.J. BD Veritor system for rapid detection of SARS-CoV-2 & Flu A+B Rapid antigen test Detects SARS-CoV-2, influenza A and influenza B in a single test Received emergency use authorization from the U.S. FDA
Binx Health Inc., of Boston Binx IO system Molecular point-of-care testing platform Detection of chlamydia and gonorrhea FDA granted CLIA waiver; had previously received 510(k) clearance for use in moderate and high-complexity locations
Gold Standard Diagnostics Group, of Davis, Calif. Borrelia burgdorferi IgG/IgM Vise-Ospc EIA test Enzyme immunoassay (EIA) that can be used in the the CDC recommended modified two-tiered testing algorithm Diagnosis of Lyme disease Received U.S. FDA clearance
Nines Inc., of Palo Alto, Calif. Ninesmeasure Artificial intelligence-based tool Helps radiologists to quickly measure the long and short axes of selected nodules in lung scans Received 510(k) clearance from the U.S. FDA

Notes

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