{"id":6978,"date":"2011-11-16T11:03:06","date_gmt":"2011-11-16T16:03:06","guid":{"rendered":"http:\/\/sciencebusiness.technewslit.com\/?p=6978"},"modified":"2011-11-16T11:03:06","modified_gmt":"2011-11-16T16:03:06","slug":"fda-approves-touch-screen-insulin-pump-system","status":"publish","type":"post","link":"https:\/\/technewslit.com\/sciencebusiness\/?p=6978","title":{"rendered":"FDA Approves Touch-Screen Insulin Pump System"},"content":{"rendered":"<figure id=\"attachment_6980\" aria-describedby=\"caption-attachment-6980\" style=\"width: 300px\" class=\"wp-caption alignright\"><a href=\"http:\/\/technewslit.com\/sciencebusiness\/wp-content\/uploads\/2011\/11\/tslim_TandemDiabetesCare.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-6980\" title=\"tslim_TandemDiabetesCare\" src=\"http:\/\/technewslit.com\/sciencebusiness\/wp-content\/uploads\/2011\/11\/tslim_TandemDiabetesCare.jpg\" alt=\"t:slim Insulin Delivery System (Tandem Diabetes Care)\" width=\"300\" height=\"202\" srcset=\"https:\/\/technewslit.com\/sciencebusiness\/wp-content\/uploads\/2011\/11\/tslim_TandemDiabetesCare.jpg 300w, https:\/\/technewslit.com\/sciencebusiness\/wp-content\/uploads\/2011\/11\/tslim_TandemDiabetesCare-150x101.jpg 150w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/a><figcaption id=\"caption-attachment-6980\" class=\"wp-caption-text\">t:slim Insulin Delivery System (Tandem Diabetes Care)<\/figcaption><\/figure>\n<p><a href=\"http:\/\/www.tandemdiabetes.com\/Content1Col.aspx?id=496\">Tandem Diabetes Care Inc.<\/a> in San Diego says the Food and Drug Administration has cleared the company&#8217;s insulin pump system for marketing in the U.S. The t:slim Insulin Delivery System, as it&#8217;s called, is one of the first insulin pumps to be cleared under the FDA\u2019s new Infusion Pump Improvement Initiative, according to the company.<\/p>\n<p>The t:slim is a programmable insulin infusion pump for people with diabetes, age 12 and older who require insulin.\u00a0 The pump&#8217;s interface features a color touch screen designed to make diabetes management easier. The device provides accurate insulin delivery from a 300-unit cartridge.<\/p>\n<p>Diabetes, according to the <a href=\"http:\/\/www.cdc.gov\/diabetes\/pubs\/pdf\/ndfs_2011.pdf\">Centers for Disease Control and Prevention<\/a>, affects 25.8 million people, about 8.3 percent of the U.S. population. It is the leading cause of kidney failure, non-traumatic lower limb amputations, and new cases of blindness among adults in the United States, a major cause of heart disease and stroke, and the seventh leading cause of death in the U.S.<\/p>\n<p>A 2008 white paper by the <a href=\"http:\/\/www.diabeteseducator.org\/export\/sites\/aade\/_resources\/pdf\/Insulin_Pump_White_Paper.pdf\">American Association of Diabetes Educators<\/a> says insulin pumps make it possible to provide diabetes patients with customized insulin dosages while reducing the risk of severe hypoglycemia. Delivery of insulin through a pump can be more consistent and precise than delivery by syringe or injection pen.<\/p>\n<p>The FDA established its <a href=\"http:\/\/www.fda.gov\/MedicalDevices\/ProductsandMedicalProcedures\/GeneralHospitalDevicesandSupplies\/InfusionPumps\/ucm202501.htm\">Infusion Pump Improvement Initiative<\/a> to address what it calls <a href=\"http:\/\/www.fda.gov\/MedicalDevices\/ProductsandMedicalProcedures\/GeneralHospitalDevicesandSupplies\/InfusionPumps\/ucm202496.htm\">persistent safety problems<\/a> with infusion pumps of all kinds, including insulin pumps, notably software errors and badly designed or confusing user controls. FDA&#8217;s program urges manufacturers of infusion pumps to meet with FDA early in the development process to identify potential issues and voluntarily submit their software for review. FDA also held a workshop for pump manufacturers and developed collaborative research projects to improve pump management software.<\/p>\n<p>Read more: <a href=\"http:\/\/sciencebusiness.technewslit.com\/?p=4107\" rel=\"prev\">FDA Approves Type 2 Diabetes Treatment<\/a><\/p>\n<p style=\"text-align: center;\">*\u00a0\u00a0\u00a0\u00a0 *\u00a0\u00a0\u00a0\u00a0 *<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Tandem Diabetes Care Inc. in San Diego says the Food and Drug Administration has cleared the company&#8217;s insulin pump system for marketing in the U.S. The t:slim Insulin Delivery System, as it&#8217;s called, is one of the first insulin pumps to be cleared under the FDA\u2019s new Infusion Pump Improvement Initiative, according to the company. [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[31,109,86,22,64,77,78],"class_list":["post-6978","post","type-post","status-publish","format-standard","hentry","category-regulations","tag-biomedical","tag-computer-science","tag-engineering","tag-fda","tag-life-sciences","tag-medical-device","tag-software"],"_links":{"self":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts\/6978","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=6978"}],"version-history":[{"count":4,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts\/6978\/revisions"}],"predecessor-version":[{"id":6983,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=\/wp\/v2\/posts\/6978\/revisions\/6983"}],"wp:attachment":[{"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=6978"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=6978"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/technewslit.com\/sciencebusiness\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=6978"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}