|3nt Medical Ltd., of Rosh Ha'ayin, Israel||Colibri Micro ENT Scope||Single-use endoscope||For visualization and illumination during otologic surgery||Received 510(k) clearance from the U.S. FDA|
|Abiomed Inc., of Danvers, Mass.||Impella RP||Temporary heart pump||Provides circulatory support for patients who develop right side ventricular failure||Received emergency use authorization from the U.S. FDA to include patients with COVID-19 related right heart failure or decompensation, including pulmonary embolism|
|Healgen Scientific LLC, of Houston, Texas||COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)||Serological test||For the qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+-heparin, K2-EDTA and sodium-citrate), and serum||Received emergency use authorization from the U.S. FDA|
|Meditech Spine LLC, of Atlanta||Cure Opel-L (S) system||Interbody/plate assembly||For anterior lumbar spinal procedures||Received 510(k) clearance from the U.S. FDA|
|Rhaeos Inc., of Evanston, Ill.||Flowsense||A wireless, noninvasive flow sensor||Monitors ventricular shunt function in patients with excess cerebrospinal fluid caused by hydrocephalus||Received breakthrough device designation by the U.S. FDA|
|Siemens Healthineers AG, of Erlangen, Germany||Atellica IM SARS-CoV-2 Total (COV2T)||Total antibody test||For the qualitative detection of antibodies against SARS-CoV-2 in human serum and plasma (potassium EDTA and lithium heparin) using the Atellica IM Analyzer||Received emergency use authorization from the U.S. FDA|
|Tissue Regenix Group plc||Orthopure XT||Decellularised xenograft ligament that enables tissue regeneration||For revision of the anterior cruciate ligament following re-rupture; also permits use for the reconstruction of other knee ligaments, including multiligament procedures following trauma||Received the CE mark|
For more information about individual companies and/or products, see Cortellis.