WASHINGTON — The FDA initiated a class I recall — its strictest — of two infusion pumps released by a single company, due to a device error which may fail to recognize in-line air in infusions. Device manufacturer Hospira warned that failure to make corrective actions before device use may cause air to be delivered [...]
Archive for the Category ◊ Drug Delivery ◊
7/14/2010 Company must provide transition guide for facilities using Colleague infusion pumps SILVER SPRING, Md., July 13 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today required Baxter Healthcare Corp. to take specific steps to carry out the April 2010 recall of all Colleague Volumetric Infusion Pumps (CVIP) and to provide customers with a refund, [...]
5/4/2010 DEERFIELD, Ill., May 03, 2010 (BUSINESS WIRE) — Baxter Healthcare Corporation today announced that it will recall COLLEAGUE infusion pumps from the U.S. market pursuant to an order under its existing June 2006 consent decree with the U.S. Food and Drug Administration (FDA). Baxter will work with the FDA to ensure that the recall [...]
The announcement of a new clinical trial, EXCEL (Evaluation of Xience Prime versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization), that will compare drug-eluting stents to coronary artery bypass graft surgery in patients with left main coronary artery disease, was made today at “Optimizing PCI Outcomes: Evolving Paradigms,” a symposium presented by [...]
IRVINE, CA–(Marketwire – 03/02/10) – Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has received CE Mark for its Edwards SAPIEN XT transcatheter aortic heart valve, as well as its NovaFlex transfemoral and Ascendra 2 transapical delivery systems. The company is beginning a disciplined [...]
“That is important, because we could attach a drug to the aptamer so that the drug could get into a cell,” said Yanrong Wu, who recently completed her doctoral research at UF. Wu was the first author of a paper describing the findings in January in the Proceedings of the National Academy of Sciences. In allowing [...]




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