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

Reuters

2025/07/07

<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.

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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</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"SG9999014674.SGD","symbol_name":"Nikko AM All China Equity A SGD","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 . 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