Allurion Technologies Submits Final PMA Module to FDA, Strengthening Case for Allurion Balloon Approval

Reuters

07-07

<a href="https://laohu8.com/S/ALUR">Allurion Technologies</a> Submits Final PMA Module to FDA, Strengthening Case for Allurion Balloon Approval

Allurion Technologies Holdings Inc., a leader in metabolically healthy weight loss solutions, has announced the submission of the fourth and final module of its Pre-Market Approval (PMA) application to the U.S. Food & Drug Administration (FDA). This submission includes additional supportive analyses from the pivotal AUDACITY Study, successfully meeting both pre-specified co-primary endpoints. The AUDACITY Study is noted for being the first FDA pivotal trial on an intragastric balloon for weight loss to report primary outcomes beyond 9 months. Dr. Shantanu Gaur, Founder and CEO of Allurion, expressed enthusiasm about the submission, emphasizing the analyses strengthen their positive topline data. The company is now looking forward to collaborating with the FDA towards obtaining approval for the Allurion Balloon.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Allurion Technologies Holdings Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250707165712) on July 07, 2025, and is solely responsible for the information contained therein.

免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。

热议股票

1
2
3
4
5
6
7
8
9
10

{"basename":"/hans","ssrTDKData":{"titleTemplate":"%s - 老虎证券","title":"老虎证券全球投资理财平台| 一站式投资美股新股港股A股","description":"老虎证券助您一站式投资美股，新股，港股，A股等全球金融理财产品。新加坡华人最信赖的在线投资平台，现在加入即享低费用，24/5 无时差炒美股投资理财！","keywords":"老虎证券,老虎证券开户,老虎券商,老虎证券官网,老虎证券app,tigertrade老虎证券,股票,炒股,新加坡股票交易平台,投资,投资理财","social":{"ogDescription":"老虎证券助您一站式投资美股，新股，港股，A股等全球金融理财产品。新加坡华人最信赖的在线投资平台，现在加入即享低费用，24/5 无时差炒美股投资理财！","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www.itiger.com/hans/news/2549534313"},"companyName":"老虎证券"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"SGP","license":"TBSG","edition":"fundamental"},"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2549534313\",edition:\"fundamental\",,,undefined,":{"share":"https://ttm.financial/m/news/2549534313?lang=zh_CN&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-07-07 20:01","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2549534313","market":"fut","top_or_hot":-1,"title":"Allurion Technologies Submits Final PMA Module to FDA, Strengthening Case for Allurion Balloon Approval","media":"Reuters","content":"<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      <a href=\"https://laohu8.com/S/ALUR\">Allurion Technologies</a> Submits Final PMA Module to FDA, Strengthening Case for Allurion Balloon Approval\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Allurion Technologies Holdings Inc., a leader in metabolically healthy weight loss solutions, has announced the submission of the fourth and final module of its Pre-Market Approval (PMA) application to the U.S. Food &amp; Drug Administration (FDA). This submission includes additional supportive analyses from the pivotal AUDACITY Study, successfully meeting both pre-specified co-primary endpoints. The AUDACITY Study is noted for being the first FDA pivotal trial on an intragastric balloon for weight loss to report primary outcomes beyond 9 months. Dr. Shantanu Gaur, Founder and CEO of Allurion, expressed enthusiasm about the submission, emphasizing the analyses strengthen their positive topline data. The company is now looking forward to collaborating with the FDA towards obtaining approval for the Allurion Balloon.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Allurion Technologies Holdings Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250707165712) on July 07, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>","source":null,"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>Allurion Technologies Submits Final PMA Module to FDA, Strengthening Case for Allurion Balloon Approval</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\">\nAllurion Technologies Submits Final PMA Module to FDA, Strengthening Case for Allurion Balloon Approval\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time\">2025-07-07 20:01</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      <a href=\"https://laohu8.com/S/ALUR\">Allurion Technologies</a> Submits Final PMA Module to FDA, Strengthening Case for Allurion Balloon Approval\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Allurion Technologies Holdings Inc., a leader in metabolically healthy weight loss solutions, has announced the submission of the fourth and final module of its Pre-Market Approval (PMA) application to the U.S. Food &amp; Drug Administration (FDA). This submission includes additional supportive analyses from the pivotal AUDACITY Study, successfully meeting both pre-specified co-primary endpoints. The AUDACITY Study is noted for being the first FDA pivotal trial on an intragastric balloon for weight loss to report primary outcomes beyond 9 months. Dr. Shantanu Gaur, Founder and CEO of Allurion, expressed enthusiasm about the submission, emphasizing the analyses strengthen their positive topline data. The company is now looking forward to collaborating with the FDA towards obtaining approval for the Allurion Balloon.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Allurion Technologies Holdings Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250707165712) on July 07, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"02018","symbol_name":"瑞声科技","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250707:nNDL4LR9Qy:1","article_id":"2549534313","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2549534313","pubTimestamp":1751889671,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Allurion Technologies Holdings Inc., a leader in metabolically healthy weight loss solutions, has announced the submission of the fourth and final module of its Pre-Market Approval  application to the U.S. Food & Drug Administration . This submission includes additional supportive analyses from the pivotal AUDACITY Study, successfully meeting both pre-specified co-primary endpoints. The AUDACITY Study is noted for being the first FDA pivotal trial on an intragastric balloon for weight loss to report primary outcomes beyond 9 months. Dr. Shantanu Gaur, Founder and CEO of Allurion, expressed enthusiasm about the submission, emphasizing the analyses strengthen their positive topline data. The company is now looking forward to collaborating with the FDA towards obtaining approval for the Allurion Balloon.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated c","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"02018":"瑞声科技","BK1607":"新IT概念","SG9999006597.SGD":"United China-India Dynamic Growth SGD","ALUR":"ALLURION TECHNOLOGIES","SG9999014674.SGD":"Nikko AM All China Equity A SGD","BK1504":"苹果概念","BK1500":"做空集合股","BK1167":"电子制造服务","BK1608":"元宇宙概念","BK4192":"特殊消费者服务"},"translate_title":"Allurion Technologies向FDA提交最终PMA模块，加强了Allurion球囊批准的理由","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"02018":0.9,"ALUR":0.9},"content_text":"Allurion Technologies Submits Final PMA Module to FDA, Strengthening Case for Allurion Balloon Approval\n    \n\n        Allurion Technologies Holdings Inc., a leader in metabolically healthy weight loss solutions, has announced the submission of the fourth and final module of its Pre-Market Approval (PMA) application to the U.S. Food & Drug Administration (FDA). This submission includes additional supportive analyses from the pivotal AUDACITY Study, successfully meeting both pre-specified co-primary endpoints. The AUDACITY Study is noted for being the first FDA pivotal trial on an intragastric balloon for weight loss to report primary outcomes beyond 9 months. Dr. Shantanu Gaur, Founder and CEO of Allurion, expressed enthusiasm about the submission, emphasizing the analyses strengthen their positive topline data. The company is now looking forward to collaborating with the FDA towards obtaining approval for the Allurion Balloon.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Allurion Technologies Holdings Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250707165712) on July 07, 2025, and is solely responsible for the information contained therein.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"code":"91000000","status":"200"}}}