Company Product Description Indication Status
Aidoc Medical, of Tel Aviv, Israel iPE flagging Artificial intelligence solution Flags incidental pulmonary embolism (iPE) in contrast-enhanced CT Received the CE mark
Cerus Corp., of Concord, Calif Intercept bloosd system for plasma Uses amotosalen and ultraviolet A illumination to irreversibly cross-link nucleic acids Reduces a broad spectrum of viruses, bacteria, protozoa, and contaminating donor leukocytes in plasma components to reduce the risk of transfusion transmitted infections Received U.S. FDA approval for manufacture of Intercept plasma with a new, alternative plastic disposable kit
Novartis Europharm Ltd., of Basel, Switzerland Enerzair Breezhaler Fixed dose combination of 3 active substances (indacaterol, glycopyrronium and mometasone furoate) in capsules, to be administered using an inhaler; electronic sensor may be attached to inhaler to track use Treatment of asthma European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion to recommend approval
Roche Holding AG, of Basel, Switzerland Elecsys Anti-SARS-CoV-2 antibody test Immunoassay; has a specificity greater than 99.8% and 100% sensitivity (14 days post-PCR confirmation); runs on Roche's Cobas E analyzers, which can provide results in 18 minutes For the in-vitro qualitative detection of antibodies (including IgG) to SARS-CoV-2 in human serum and plasma Received emergency use authorization from the U.S. FDA
Zoll Medical Corp., of Chelmsford, Mass. Supersaturated Oxygen (SSO2) Therapy system Delivers hyperbaric levels of oxygen directly to the damaged heart muscle immediately after successful revascularization via angioplasty and stenting of the blocked coronary artery For patients who experience left anterior descending ST-elevation myocardial infarction Received CE mark approval


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

No Comments