Medtronic receives FDA clearance for new InPen™ app, paving the way for its Smart MDI system launch with Simplera™ CGM

PR Newswire11-20 21:30

New Smart MDI system will be the first system to deliver real-time, personalized insights on when and how much to dose including for missed or inaccurate mealtime doses. GALWAY, Ireland, Nov. 20, ...

Source Link

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2484110326?lang=en_US&edition=fundamental","thumbnail":"https://s.yimg.com/uu/api/res/1.2/pxgWs7oh_uqH7I4V_jlM9A--~B/aD0zNzY7dz00MDA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/prnewswire.com/92cc2c1c7c18be56812a7bb2f8373d94","is_english":true,"pubTime":"2024-11-20 21:30","share_image_url":"https://static.laohu8.com/5f26f4a48f9cb3e29be4d71d3ba8c038","id":"2484110326","market":"us","top_or_hot":-1,"title":"Medtronic receives FDA clearance for new InPen™ app, paving the way for its Smart MDI system launch with Simplera™ CGM","media":"PR Newswire","content":"<div>\n<p>New Smart MDI system will be the first system to deliver real-time, personalized insights on when and how much to dose including for missed or inaccurate mealtime doses. \nGALWAY, Ireland, Nov. 20, ...</p>\n\n<a href=\"https://finance.yahoo.com/news/medtronic-receives-fda-clearance-inpen-133000415.html\">Source Link</a>\n\n</div>\n","source":"yahoofinance","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Medtronic receives FDA clearance for new InPen™ app, paving the way for its Smart MDI system launch with Simplera™ CGM</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nMedtronic receives FDA clearance for new InPen™ app, paving the way for its Smart MDI system launch with Simplera™ CGM\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-11-20 21:30 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/medtronic-receives-fda-clearance-inpen-133000415.html><strong>PR Newswire</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>New Smart MDI system will be the first system to deliver real-time, personalized insights on when and how much to dose including for missed or inaccurate mealtime doses. \nGALWAY, Ireland, Nov. 20, ...</p>\n\n<a href=\"https://finance.yahoo.com/news/medtronic-receives-fda-clearance-inpen-133000415.html\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU1989764664.SGD","symbol_name":"CPR Invest - Global Disruptive Opportunities A2 Acc SGD-H","start_time":0,"source_url":"https://finance.yahoo.com/news/medtronic-receives-fda-clearance-inpen-133000415.html","article_id":"2484110326","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/pxgWs7oh_uqH7I4V_jlM9A--~B/aD0zNzY7dz00MDA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/prnewswire.com/92cc2c1c7c18be56812a7bb2f8373d94"],"rights":{"source":"yahoofinance","url":"https://finance.yahoo.com/news/medtronic-receives-fda-clearance-inpen-133000415.html","rn_cache_url":null,"customStyle":"img, svg { display: none !important; }","selectors":"article","filters":"","directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2484110326","pubTimestamp":1732109400,"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"New Smart MDI system will be the first system to deliver real-time, personalized insights on when and how much to dose including for missed or inaccurate mealtime doses.GALWAY, Ireland, Nov. 20, 2024 /PRNewswire/ -- Medtronicplc , a global leader in healthcare technology, today announced U.S. Food and Drug Administration  clearance for its new InPen app featuring missed meal dose detection, paving the way for the launch of its Smart MDI system with the Simplera continuous glucose monitor . The company's Smart MDI system combines its InPen smart insulin pen with its newest Simplera CGM — the company's first disposable, all-in-one CGM that's half the size of previous Medtronic CGMs.With this clearance, the system will be the first in the market to recommend corrections for missed or inaccurate insulin doses, providing real-time, personalized insights for individuals on multiple daily injection  therapy.","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU1989764664.SGD":"CPR Invest - Global Disruptive Opportunities A2 Acc SGD-H","LU2089284900.SGD":"Allianz Global Sustainability Cl AM Dis H2-SGD","LU2028103732.USD":"ALLIANZ GLOBAL SUSTAINABILITY \"AMG\" (USD) INC","IE00BFXG1179.USD":"BNY MELLON U.S. EQUITY INCOME \"B\" (USD) INC","LU1989764748.USD":"东方汇理环球颠覆性机遇A2 Acc","LU0158827781.USD":" ALLIANZ GLOBAL SUSTAINABILITY \"AT\" (USD) ACC","LU0072461881.USD":"BGF US BASIC VALUE \"A2\" ACC","LU0320765489.SGD":"FTIF - Franklin Mutual US Value A Acc SGD","IE00B3T34201.USD":"BNY MELLON GLOBAL EQUITY INCOME \"B\" (USD) INC","LU0496365809.HKD":"TEMPLETON GLOBAL INCOME \"A\" (HKD) INC (Q)","LU0070302665.USD":"FRANKLIN MUTUAL U.S. VALUE \"A\" (USD) ACC","LU0211326755.USD":"TEMPLETON GLOBAL INCOME \"A\" (USD) ACC","IE00BQXX3D17.EUR":"GUINNESS GLOBAL INNOVATORS \"C\" (EUR) ACC","LU0158827948.USD":"ALLIANZ GLOBAL SUSTAINABILITY \"A\" (USD) INC","LU1571399168.USD":"ALLSPRING GLOBAL LONG/SHORT EQUITY \"IP\" (USD) ACC","IE00BQXX3C00.GBP":"GUINNESS GLOBAL INNOVATORS \"C\" (GBP) ACC","LU2089283258.USD":"安联环球可持续基金Cl AM Dis","IE00BQXX3F31.USD":"GUINNESS GLOBAL INNOVATORS \"C\" (USD) ACC","LU0976567544.SGD":"FTIF - Templeton Global Income A Mdis SGD-H1","LU2111349929.HKD":"ALLIANZ GLOBAL SUSTAINABILITY \"AM\" (HKD) INC","LU0211326839.USD":"TEMPLETON GLOBAL INCOME \"A\" (USD) INC","BK4585":"ETF&股票定投概念","LU0211331839.USD":"FRANKLIN MUTUAL GLB DISCOVERY \"A\" (USD) ACC","LU1291159041.SGD":"CPR Invest - Global Silver Age A2 Acc SGD-H","MDT":"美敦力","BK4533":"AQR资本管理(全球第二大对冲基金)","LU0162691827.USD":"BGF US BASIC VALUE \"A4\" INC","BK4566":"资本集团","LU1989771016.USD":"东方汇理环球老龄化投资基金 A2 Acc","LU2271345857.HKD":"ALLIANZ GLOBAL SUSTAINABILITY \"AT\" (HKD) ACC","BK4082":"医疗保健设备","LU2023251221.USD":"ALLIANZ GLOBAL SUSTAINABILITY \"AM\" (USD) INC","LU0208291251.USD":"FRANKLIN MUTUAL U.S. VALUE \"A\" (USD) INC","GRO":"Brazil Potash Corp.","BK4588":"碎股"},"translate_title":"美敦力新InPen™应用程序获得FDA许可，为其与Simplera™CGM合作推出智能MDI系统铺平道路","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"GRO":1,"MDT":0.9},"content_text":"New Smart MDI system will be the first system to deliver real-time, personalized insights on when and how much to dose including for missed or inaccurate mealtime doses. \nGALWAY, Ireland, Nov. 20, 2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced U.S. Food and Drug Administration (FDA) clearance for its new InPen™ app featuring missed meal dose detection, paving the way for the launch of its Smart MDI system with the Simplera™ continuous glucose monitor (CGM). The company's Smart MDI system combines its InPen™ smart insulin pen with its newest Simplera™ CGM — the company's first disposable, all-in-one CGM that's half the size of previous Medtronic CGMs.\nWith this clearance, the system will be the first in the market to recommend corrections for missed or inaccurate insulin doses, providing real-time, personalized insights for individuals on multiple daily injection (MDI) therapy. \n\n\n\nFor people with diabetes who need daily insulin injections, bolusing before a meal is essential as it helps regulate glucose levels and prevent blood sugar spikes after eating. Minimizing the frequency of these glucose highs reduces the risk of both short- and long-term complications and supports better overall health. However, it's estimated that individuals living with diabetes regularly miss 1 out of 3 doses. The Missed Dose alert function helps to minimize the frequency of these glucose highs.1 The Medtronic Smart MDI system reduces the guesswork out of diabetes management, helping to address a significant unmet need for MDI users who struggle with juggling numerous decisions related to insulin dosing on a daily basis.  \n\"I'm thrilled about the launch of the Medtronic Smart MDI system with the InPen™ app and Simplera™ CGM. This is a significant leap forward for those on multiple daily injections, offering intelligent dosing insights and simplifying diabetes management,\" said Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP. \"By reducing the guesswork out of insulin dosing, this tool helps maintain stable blood sugars, optimize long-term health, and reduce complications from hyperglycemia.\"2,3\nMedtronic will initiate a limited market release beginning with existing standalone CGM and InPen™ customers followed by a broad commercial launch.   \n\n\n\n\n1. MacLeod, J, Heungyong Im, G, Smith, M, Vigersky, RA. Shining the Spotlight on Multiple Daily Insulin Therapy: Real-World Evidence of the InPen Smart Insulin Pen. Diabetes Technology & Therapeutics. 2024. 26:1, 33-39. \n\n\n2. Vigersky et al., Impact Of InPen Smart Insulin Pen Use on Real-World Glycemic and Insulin Dosing Outcomes in Individuals with Poorly Controlled Diabetes. Presented at: American Diabetes Association; 81st Scientific Sessions; 2021 Jun 25-29. \n\n\n3. Chien A, Thanasekaran S, Gaetano A, Im G, Wherry K, MacLeod J, Vigersky RA. Potential cost savings in the United States from a reduction in sensor-detected severe hypoglycemia among users of the InPen smart insulin pen system. J Manag Care Spec Pharm. 2023 Mar;29(3):285-292. \n\n\n\n\nAbout the Diabetes Business at Medtronic (www.medtronicdiabetes.com)Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.\nAbout MedtronicBold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn.\nAny forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.\n\n\n\n\nContacts:  \n\n\n\n\nJanet Cho \nRyan Weispfenning  \n\n\n\nPublic Relations \nInvestor Relations  \n\n\n\n+1-818-403-7028 \n+1-763-505-4626  \n\n\n\n\n\n\n\n\n\n\n View original content to download multimedia:https://www.prnewswire.com/news-releases/medtronic-receives-fda-clearance-for-new-inpen-app-paving-the-way-for-its-smart-mdi-system-launch-with-simplera-cgm-302310779.html\nSOURCE Medtronic plc","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"Product Release","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.2","shortVersion":"4.29.2","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2484110326"}