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.
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