The U.S. FDA announced that it has cleared a new set of tubes used in hemodialysis machines made by Fresenius Medical Care AG & Co., of Bad Homburg, Germany, that are expected to overcome concerns about the previous tubes’ release of potentially toxic biphenyls. The agency acknowledged that it has no reports of adverse events related to the use of these chemicals in the silicone used to manufacture the tubes, stating that its action on this issue is driven solely by animal studies in the medical literature, none of which were cited in the FDA’s Oct. 28 announcement.
After a long approval process, Monmouth Junction N.J.-based Cytosorbents Corp. received clearance to bring its Cytosorb blood purification technology to treat cytokine storm and deadly inflammation in critically ill and cardiac surgery patients, to the Mexican market. The COVID-19 pandemic may delay marketing plans to roll-out the product in the Latin American country.
The U.S. FDA has given its nod to Novalung, a heart and lung support system from Fresenius Medical Care North America (FMCNA) for the treatment of acute respiratory or cardiopulmonary failure. The Waltham, Mass.-based company noted that Novalung is the first extracorporeal membrane oxygenation (ECMO) system to be cleared for more than six hours of use.