|Becton, Dickinson and Co. (BD), of Franklin Lakes, N.J.||BD Facslyric||Flow cytometer with the integrated BD Facsduet sample preparation system||Enables clinical laboratories to fully automate the sample to answer process||Received 510(k) clearance from the U.S. FDA|
|Chembio Diagnostics Inc., of of Medford, N.Y.||Dpp HIV-Syphilis system||Includes the Dpp HIV-Syphilis assay, a multiplex single-use test and the Dpp Micro Reader optical analyzer||Detects antibodies to HIV types 1 and 2 and Treponema pallidum, the bacteria that causes syphilis||Received premarket approval from the U.S. FDA|
|Haemonetics Corp., of Boston||Nexsys PCS system with Persona technology||Plasma collection system (PCS) with automated blood cell separator||Customizes plasma collection based on an individual donor's body composition||Received 510(k) clearance from the U.S. FDA|
|Histosonics Inc., of Plymouth, Minn.||Histosonics system||Sonic beam therapy platform that utilizes the science of histotripsy||Mechanically destroys targeted liver tissue and tumors from outside of the body||Received approval of an investigational device exemption from the U.S. FDA to begin its #HOPE4LIVER clinical study to evaluate safety and efficacy|
|Pixcell Medical Technologies Ltd., of Yokneam Illit, Israel||Hemoscreen||Hematology analyzer that offers a 5-part differential complete blood count intended for point-of-care use||Provides accurate readings of 20 standard blood count parameters, as well as comprehensive abnormal cell flagging, which can assist in the early detection of disease||Received approval from the Australian Therapeutic Goods Administration|
|Quidel Corp., of San Diego||Sofia 2 Flu + SARS Antigen FIA||Rapid point-of-care test to be used with the Sofia 2 Fluorescent Immunoassay Analyzer (FIA)||For the simultaneous qualitative detection and differentiation of the nucleocapsid protein antigens from SARS-CoV-2, influenza A and influenza B in direct nasopharyngeal and nasal swab specimens||Received emergency use authorization from the U.S. FDA|
For more information about individual companies and/or products, see Cortellis.