Animas Corporation Receives FDA 510k Clearance for Its Diabetes Management Software System.Business Editors/Health/Medical Writers FRAZER, Pa.--(BUSINESS WIRE)--June 19, 2003 Animas Corporation, a manufacturer of insulin infusion pumps infusion pump A device designed to deliver drugs and/or 'biologicals', at low doses and at a constant or controllable rate; ↑ rates of delivery in such devices may be associated with local hemolysis, compromising the potential benefits of a calibrated delivery and other products for patients with insulin-requiring diabetes, announced today that it has received US Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) 510(k) clearance to market ezManager Plus. ezManager Plus, the first software system of its kind to receive FDA 510(k) clearance, differs from other available systems with its comprehensive food database, carbohydrate calculator, and ability to accept download information from both the Animas IR 1000 insulin pump insulin pump n. A portable device for people with diabetes that injects insulin at programmed intervals in order to regulate blood sugar levels. and a variety of blood glucose blood glucose Diabetology The principal sugar produced by the body from food–especially carbohydrates, but also from proteins and fats; glucose is the body's major source of energy, is transported to cells via the circulation and used by cells in the presence meters. This software system, with both a Palm-OS and desktop module, is designed to help people better manage their diabetes and help reduce the time healthcare professionals need to spend helping patients manage diabetes. With this intuitive program, patients can: -- Access a database of more than 3,000 different foods, including fast food restaurants and customized favorites, -- Record daily activity on a personal digital assistant (PDA (Personal Digital Assistant) A handheld computer for managing contacts, appointments and tasks. It typically includes a name and address database, calendar, to-do list and note taker, which are the functions in a personal information manager (see PIM). ), -- Automatically calculate insulin needs for carbohydrate intake and blood glucose readings, -- Download and electronically send insulin pump history, blood glucose meter A glucose meter (or glucometer) is a medical device for determining the approximate concentration of glucose in the blood. It is a key element of home blood glucose monitoring (HBGM) by people with diabetes mellitus or with proneness to hypoglycemia. and PDA records, and -- Do trending analysis and obtain other statistical analysis. Commenting on the FDA clearance, Dr. Katherine Crothall, Animas' CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. said, "Managing diabetes properly is very time-intensive for patients and their healthcare teams. Patients need to adjust their insulin intake based upon the carbohydrate content of their meal and current blood glucose readings, necessitating patients thumbing through food databases and performing multi-step computations. Many patients simply make wild guesses. ezManager Plus removes much of the guesswork and significantly simplifies the time-intensive computations. "We are also committed to developing tools that reduce the strain on the already over-burdened healthcare system. The reports available from ezManager Plus give patients and the healthcare team a comprehensive view of important parameters of diabetes management This article is about the management of diabetes mellitus. For more on the disease itself see diabetes mellitus. Diabetes is a chronic disease with no cure as of 2007. It is associated with an impaired glucose cycle, altering metabolism. and allow healthcare professionals to focus more efficiently on developing treatment plans for their patients," Dr. Crothall explains. About Animas Corporation: Animas, a leading maker of insulin infusion pumps and related products, is dedicated to improving diabetes management and making insulin pump therapy easier for patients with insulin-requiring diabetes and healthcare professionals through product innovation, exemplary customer support and superior customer education. For more information on Animas, visit www.animascorp.com or call Animas Corporation at 877-937-7867. |
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