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The FDA has issued a statement following the Class I recall for an IOS app used in conjunction with insulin pumps after 224 injuries were reported.
Roche acquired Syntex in 1994, and Chugai Pharmaceuticals in 2002. Oseltamivir an antiviral drug used to combat influenza. Roche is the only drug company authorized to manufacture the drug, which was discovered by Gilead Sciences. Roche purchased the rights to the drug in 1996, and in 2005, settled a royalty dispute, agreeing to pay Gilead ...
Insulin pumps, cartridges, and infusion sets may be far more expensive than syringes used for insulin injection with several insulin pumps costing more than $6,000; necessary supplies can cost over $300. [3] Another disadvantage of insulin pump use is a higher risk of developing diabetic ketoacidosis if the pump malfunctions. [3]
The Tandem Diabetes Care t:Slim X2 was approved by the U.S. Food and Drug Administration in 2019 and is the first insulin pump to be designated as an alternate controller enabled (ACE) insulin pump. ACE insulin pumps allow users to integrate continuous glucose monitors, automated insulin dosing (AID) systems, and other diabetes management ...
Abiomed's so-called recall of some models of its Impella Left Sided Blood Pumps, used in some high-risk heart procedures to provide short-term support, was because of the possibility they could ...
(Reuters) - The U.S. Food and Drug Administration (FDA) on Friday said it had identified the recall of B. Braun Medical Inc's medicine-delivering pump system as most serious.
In November 2011, the company received FDA clearance to market the t:slim Insulin Pump, the first ever touch-screen insulin pump. [10] In February 2013, the company received FDA clearance to market the t:connect Diabetes Management Application, a Mac and PC-compatible data management application that provides t:slim Pump users and their healthcare providers a way to display data from the pump ...
The dilution of insulin is such that 1 mL of insulin fluid has 100 standard "units" of insulin. [6] A typical insulin vial may contain 10 mL, for 1000 units. Insulin syringes are made specifically for a patient to inject themselves, and have features to assist this purpose when compared to a syringe for use by a healthcare professional:
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