Company Product Description Indication Status
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


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